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Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. Assuming that roughly 15% of the subjects will be lost-to-follow-up, a total of up to 400 subjects (200 per treatment arm) will be enrolled in the study at up to 60 sites in Europe, the United States and New Zealand.
In addition to the randomized study, an observational study of subjects who do not meet the inclusion/exclusion criteria for the randomized study will be conducted. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Peripheral Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.
The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study.
A maximum of 1500 subjects at the same 60 sites will be enrolled in the observational study. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria.
Results for the observational study will be reported in a separate record under NCT05881421.
Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. The Shockwave Medical Peripheral Lithoplasty System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. Up to 400 subjects at 60 sites in Europe, the United States and New Zealand.
Subjects will be followed through discharge, 30 days, and 6, 12 and 24 months. DUS assessments will be completed at 12 and 24 months. Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab.
Subjects who do not meet the randomized study inclusion and exclusion criteria, but meet the inclusion and exclusion criteria for the observational study may be enrolled in the observational study. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study. A maximum of 1500 subjects at the same 60 sites will be enrolled in the observational study. Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab. Enrollment in the observational study is anticipated to last approximately 22 months. Subjects in the observational study will be followed through hospital discharge. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria. Results for the observational study will be reported in a separate record under NCT05881421.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lithoplasty System followed by DCB | Experimental | Shockwave Lithoplasty® Peripheral Lithoplasty System is a lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. lithoplasty |
|
| Medtronic IN.PACT (DCB) | Active Comparator | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shockwave Lithoplasty® Peripheral Lithoplasty System | Device | The Shockwave Lithoplasty® System is a proprietary lithotripsy-enhanced balloon catheter that is designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Procedural Success | Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab. | Peri-Procedural, approximately 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Adverse Events (MAEs) |
| 30 days |
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Randomized Study Arm Eligibility Criteria
General Inclusion Criteria
Subject is able and willing to comply with all assessments in the study.
Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
Age of subject is greater than or equal to 18.
Rutherford Clinical Category 2, 3, or 4 of the target limb.
Estimated life expectancy >1 year.
Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.
Subject is intended to undergo treatment with Lithoplasty followed by DCB, or DCB with standard balloon pre-dilatation.
Angiographic Inclusion Criteria
Target lesion that is located in a native, de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery).
Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.
Target lesion is ≥70% stenosis by investigator via visual estimate.
Target lesion length is ≤180mm for lesions 70-99% stenosed. Target lesion can be all or part of the 180mm treated zone.
Chronic total occlusion, lesion length is ≤100mm of the total ≤180 mm target lesion.
Subject has at least one patent tibial vessel on the target leg with runoff to the foot, defined as no stenosis >50%.
Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length.
General Exclusion Criteria
Rutherford Clinical Category 0, 1, 5 and 6.
Subject has active infection requiring antibiotic therapy.
Planned target limb major amputation (above the ankle).
History of prior endovascular or surgical procedure on the index limb within the past 30 days or planned within 30 days of the index procedure.
Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter.
Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
Subject has known allergy to urethane, nylon, or silicone.
Myocardial infarction within 60 days prior to enrollment.
History of stroke within 60 days prior to enrollment.
History of thrombolytic therapy within two weeks of enrollment.
Subject has acute or chronic renal disease defined as serum creatinine of >2.5 mg/dL or >220 umol/L, or on dialysis.
Subject is pregnant or nursing.
Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
The use of specialty balloons, re-entry or atherectomy devices.
Angiographic Exclusion Criteria
In-stent restenosis within 10mm of the target zone.
Lesions within 10mm of the ostium of the SFA or within 10mm of the ostium of the anterior tibial artery.
Evidence of aneurysm or thrombus in target vessel.
No calcium or mild calcium in the target lesion.
Target lesion within native or synthetic vessel grafts.
Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated.
Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to target site at the time of the index procedure.
Failure to successfully cross the guidewire across the target lesion; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations.
Subjects who do not meet the inclusion/exclusion criteria for the randomized study may satisfy the eligibility criteria for the observational study.
Observational Study Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Gunnar Tepe, MD | RoMed Klinikum Rosenheim | Principal Investigator |
| William A Gray, MD | Main Line Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States | ||
| Stanford Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37925039 | Derived | Nagpal S, Altin SE, McGinigle K, Mangalmurti SS, Adams G, Shammas NW, Mehrle A, Soukas P, Bertolet B, Lansky AJ. Sex-specific analysis of intravascular lithotripsy for peripheral artery disease from the Disrupt PAD III observational study. J Vasc Surg. 2024 Feb;79(2):358-365. doi: 10.1016/j.jvs.2023.10.058. Epub 2023 Nov 2. | |
| 34167675 |
| Label | URL |
|---|---|
| Intravascular lithotripsy for treatment of calcified, stenotic iliac arteries: A cohort analysis from the Disrupt PAD III Study | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lithoplasty System Followed by DCB | Shockwave Lithoplasty® Peripheral Lithoplasty System is a lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. lithoplasty Shockwave Lithoplasty® Peripheral Lithoplasty System: The Shockwave Lithoplasty® System is a proprietary lithotripsy-enhanced balloon catheter that is designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2019 |
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|
| Medtronic IN.PACT (DCB) | Drug | The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| Clinical Success ABI | Defined as ankle-brachial index ABI reported at 30 days as change from baseline. The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease. | 30 days |
| Clinical Success Quality of Life | Defined by Quality of Life assessed by EQ5D questionnaire reported at 30 days as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied. It ranges from 0.000 to 1.000; higher scores indicate better patient-reported health status." | 30 days |
| Clinical Success Rutherford Category | Defined as Rutherford Category reported at 30 days as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene. | 30 days |
| Number of Participants With Clinically-driven Target Lesion Revascularization (TLR) | Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI >20% or >0.15 when compared to the 30-day ABI and associated with an angiographic lesion >50% at the target lesion site | 30 days |
| Number of Participants With Major Adverse Events (MAEs) |
| 6 months |
| Clinical Success Rutherford Category | Defined as Rutherford Category reported at 6 months as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene. | 6 months |
| Number of Participants With Clinically-driven Target Lesion Revascularization (TLR) | Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI >20% or >0.15 when compared to the 30-day ABI and associated with an angiographic lesion >50% at the target lesion site | 6 months |
| Clinical Success ABI | Defined as ankle-brachial index ABI reported at 6 months as change from baseline. The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease. | 6 months |
| Clinical Success Quality of Life | Defined by Quality of Life assessed by EQ5D questionnaire reported at 6 months as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied and ranges from 0.000 to 1.000; higher scores indicate better patient-reported health status. | 6 months |
| Number of Participants With Primary Patency | Defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis determined by duplex ultrasound or angiogram greater than or equal to 50% stenosis. | 12 months |
| Number of Participants With Major Adverse Events (MAEs) |
| 12 months |
| Number of Participants With Clinically-driven Target Lesion Revascularization (TLR) | Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI >20% or >0.15 when compared to the 30-day ABI and associated with an angiographic lesion >50% at the target lesion site | 12 months |
| Clinical Success ABI | Defined as ankle-brachial index ABI reported at 12 months as change from baseline. The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease. | 12 months |
| Clinical Success Rutherford Category | Defined as Rutherford Category reported at 12 months as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene. | 12 months |
| Clinical Success Quality of Life | Defined by Quality of Life assessed by EQ5D questionnaire reported at 12 months as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied and ranges from 0.000 to 1.000; higher scores indicate better patient-reported health status. | 12 months |
| Number of Participants With Primary Patency | Defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis determined by duplex ultrasound or angiogram greater than or equal to 50% stenosis. | 24 months |
| Number of Participants With Major Adverse Events (MAEs) |
| 24 months |
| Number of Participants With Clinically-driven Target Lesion Revascularization (TLR) | Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI >20% or >0.15 when compared to the 30-day ABI and associated with an angiographic lesion >50% at the target lesion site | 24 months |
| Clinical Success ABI | Defined as ankle-brachial index ABI reported at 24 months as change from baseline. The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease. | 24 months |
| Clinical Success Rutherford Category | Defined as Rutherford Category reported at 24 months as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene. | 24 months |
| Clinical Success Quality of Life | Defined by Quality of Life assessed by EQ5D questionnaire reported at 24 months as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied and ranges from 0.000 to 1.000; higher scores indicate better patient-reported health status. | 24 months |
| Palo Alto |
| California |
| 94304 |
| United States |
| Rocky Mountain Regional VA Medical Center | Aurora | Colorado | 80045 | United States |
| UCHealth Northern Colorado | Loveland | Colorado | 80538 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| MedStar Cardiovascular Research Network @ Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Tallahassee Research Institute, Inc. | Tallahassee | Florida | 32308 | United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Alexian Brothers Medical Center | Elk Grove Village | Illinois | 60007 | United States |
| Advocate Health and Hospitals Corporation | Naperville | Illinois | 60540 | United States |
| Prairie Education & Research Cooperative | Springfield | Illinois | 62769 | United States |
| Midwest Cardiovascular Research Foundation | Davenport | Iowa | 52803 | United States |
| Steward St. Elizabeth's Medical Center | Brighton | Maine | 02135 | United States |
| St. Joseph Mercy Oakland | Pontiac | Michigan | 48431 | United States |
| Ascension / St. John Providence | Southfield | Michigan | 48075 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| Saint Luke's Cardiovascular Consultants | Kansas City | Missouri | 64111 | United States |
| St. Luke's East Hospital | Lee's Summit | Missouri | 64086 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Mount Sinai West | New York | New York | 10019 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Medical Center/New York Presbyterian Hospital | New York | New York | 10032 | United States |
| NC Heart & Vascular Research | Raleigh | North Carolina | 27607 | United States |
| WakeMed Health & Hospitals | Raleigh | North Carolina | 27610 | United States |
| Ohio Health Research Institute | Columbus | Ohio | 43214 | United States |
| St. John Clinic | Bartlesville | Oklahoma | 74006 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Providence Heart & Vascular Institute | Portland | Oregon | 97225 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| PinnacleHealth Harrisburg Hospital | Harrisburg | Pennsylvania | 17101 | United States |
| Einstein Medical Center Philadelphia | Philadelphia | Pennsylvania | 19141 | United States |
| Lankenau Institute for Medical Research | Wynnewood | Pennsylvania | 19096 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Wellmont CVA Heart Institute | Kingsport | Tennessee | 37660 | United States |
| Tennova Healthcare - Turkey Creek Medical Center | Knoxville | Tennessee | 37934 | United States |
| Baptist Medical Center | Memphis | Tennessee | 38120 | United States |
| St. David's Heart and Vascular dba Austin Heart | Austin | Texas | 78756 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Charleston Area Medical Center | Charleston | West Virginia | 25304 | United States |
| Medizinische Universitaet Graz | Graz | 8036 | Austria |
| Gefäßsambulanz | Vienna | 1140 | Austria |
| Karolinen-Hospital | Arnsberg | 59759 | Germany |
| Universitäts-Herzzentrum Freiburg & Bad Krozingen | Bad Krozingen | 79189 | Germany |
| Sankt Gertrauden-Krankenhaus | Berlin | 10713 | Germany |
| Leiter Sektion Angiologie | Bonn | 53127 | Germany |
| Medizinische Klinik II | Bruchsal | 76646 | Germany |
| Klinik für Gefäßmedizin | Hamburg | 21075 | Germany |
| Universitätsklinikum Leipzig AoR Leipzig | Leipzig | 04103 | Germany |
| Katholisches Klinikum Mainz | Mainz | 55131 | Germany |
| Evangelisches Krankenhaus Mühlheim an der Ruhr | Mülheim | 45468 | Germany |
| St. Franziskus Hospital | Münster | 48145 | Germany |
| RoMed Klinikum Rosenheim | Rosenheim | 83022 | Germany |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Tepe G, Brodmann M, Werner M, Bachinsky W, Holden A, Zeller T, Mangalmurti S, Nolte-Ernsting C, Bertolet B, Scheinert D, Gray WA; Disrupt PAD III Investigators. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361. doi: 10.1016/j.jcin.2021.04.010. |
| 32242768 | Derived | Adams G, Shammas N, Mangalmurti S, Bernardo NL, Miller WE, Soukas PA, Parikh SA, Armstrong EJ, Tepe G, Lansky A, Gray WA. Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study. J Endovasc Ther. 2020 Jun;27(3):473-480. doi: 10.1177/1526602820914598. Epub 2020 Apr 3. |
| FG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lithoplasty System Followed by DCB | Shockwave Lithoplasty® Peripheral Lithoplasty System is a lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. lithoplasty Shockwave Lithoplasty® Peripheral Lithoplasty System: The Shockwave Lithoplasty® System is a proprietary lithotripsy-enhanced balloon catheter that is designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
| BG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Procedural Success | Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab. | Posted | Count of Participants | Participants | Peri-Procedural, approximately 2 hours |
|
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| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Adverse Events (MAEs) |
| Posted | Count of Participants | Participants | 30 days |
| ||||||||||||||||||||||||||||||||
| Secondary | Clinical Success ABI | Defined as ankle-brachial index ABI reported at 30 days as change from baseline. The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease. | Posted | Mean | Standard Deviation | index | 30 days |
| |||||||||||||||||||||||||||||||
| Secondary | Clinical Success Quality of Life | Defined by Quality of Life assessed by EQ5D questionnaire reported at 30 days as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied. It ranges from 0.000 to 1.000; higher scores indicate better patient-reported health status." | Posted | Mean | Standard Deviation | units on a scale | 30 days |
| |||||||||||||||||||||||||||||||
| Secondary | Clinical Success Rutherford Category | Defined as Rutherford Category reported at 30 days as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene. | Posted | Mean | Standard Deviation | units on a scale | 30 days |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically-driven Target Lesion Revascularization (TLR) | Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI >20% or >0.15 when compared to the 30-day ABI and associated with an angiographic lesion >50% at the target lesion site | Posted | Count of Participants | Participants | 30 days |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Adverse Events (MAEs) |
| Posted | Count of Participants | Participants | 6 months |
| ||||||||||||||||||||||||||||||||
| Secondary | Clinical Success Rutherford Category | Defined as Rutherford Category reported at 6 months as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically-driven Target Lesion Revascularization (TLR) | Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI >20% or >0.15 when compared to the 30-day ABI and associated with an angiographic lesion >50% at the target lesion site | Posted | Count of Participants | Participants | 6 months |
| ||||||||||||||||||||||||||||||||
| Secondary | Clinical Success ABI | Defined as ankle-brachial index ABI reported at 6 months as change from baseline. The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
| |||||||||||||||||||||||||||||||
| Secondary | Clinical Success Quality of Life | Defined by Quality of Life assessed by EQ5D questionnaire reported at 6 months as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied and ranges from 0.000 to 1.000; higher scores indicate better patient-reported health status. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Primary Patency | Defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis determined by duplex ultrasound or angiogram greater than or equal to 50% stenosis. | Posted | Count of Participants | Participants | 12 months |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Adverse Events (MAEs) |
| Posted | Count of Participants | Participants | 12 months |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically-driven Target Lesion Revascularization (TLR) | Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI >20% or >0.15 when compared to the 30-day ABI and associated with an angiographic lesion >50% at the target lesion site | Posted | Count of Participants | Participants | 12 months |
| ||||||||||||||||||||||||||||||||
| Secondary | Clinical Success ABI | Defined as ankle-brachial index ABI reported at 12 months as change from baseline. The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
| |||||||||||||||||||||||||||||||
| Secondary | Clinical Success Rutherford Category | Defined as Rutherford Category reported at 12 months as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
| |||||||||||||||||||||||||||||||
| Secondary | Clinical Success Quality of Life | Defined by Quality of Life assessed by EQ5D questionnaire reported at 12 months as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied and ranges from 0.000 to 1.000; higher scores indicate better patient-reported health status. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Primary Patency | Defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis determined by duplex ultrasound or angiogram greater than or equal to 50% stenosis. | Posted | Count of Participants | Participants | 24 months |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Adverse Events (MAEs) |
| Posted | Count of Participants | Participants | 24 months |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically-driven Target Lesion Revascularization (TLR) | Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI >20% or >0.15 when compared to the 30-day ABI and associated with an angiographic lesion >50% at the target lesion site | Posted | Count of Participants | Participants | 24 months |
| ||||||||||||||||||||||||||||||||
| Secondary | Clinical Success ABI | Defined as ankle-brachial index ABI reported at 24 months as change from baseline. The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease. | Posted | Mean | Standard Deviation | units on a scale | 24 months |
| |||||||||||||||||||||||||||||||
| Secondary | Clinical Success Rutherford Category | Defined as Rutherford Category reported at 24 months as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene. | Posted | Mean | Standard Deviation | units on a scale | 24 months |
| |||||||||||||||||||||||||||||||
| Secondary | Clinical Success Quality of Life | Defined by Quality of Life assessed by EQ5D questionnaire reported at 24 months as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied and ranges from 0.000 to 1.000; higher scores indicate better patient-reported health status. | Posted | Mean | Standard Deviation | units on a scale | 24 months |
|
Follow-up data was collected through 24 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lithoplasty System Followed by DCB | Shockwave Lithoplasty® Peripheral Lithoplasty System is a lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. lithoplasty Shockwave Lithoplasty® Peripheral Lithoplasty System: The Shockwave Lithoplasty® System is a proprietary lithotripsy-enhanced balloon catheter that is designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. | 17 | 153 | 87 | 153 | 134 | 153 |
| EG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. | 12 | 153 | 91 | 153 | 135 | 153 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthritis infective | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Wound abscess | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Abdominal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Appendix cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Gastrointestinal tract adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Hypopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Hypopharyngeal cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Lymphocele | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Adult failure to thrive | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Peroneal nerve injury | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Spinal claudication | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Vertebral lateral recess stenosis | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Blepherochalasis | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Neovascular age-related macular degeneration | Eye disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Chronic left ventricular failure | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Endocarditis | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Arterial bypass occlusion | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Brain stem stroke | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Carotid artery disease | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Carotid artery stenosis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cerebral infarction | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Coronary artery occlusion | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Iliac artery restenosis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Iliac artery stenosis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Intraventricular haemorrhage | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Ischaemic stroke | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Penetrating aortic ulcer | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Peripheral arterial reocclusion | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Peripheral artery dissection | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Peripheral artery restenosis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Presyncope | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Skin ulcer | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Syncope | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Vascular graft occlusion | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Vascular stent stenosis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Vascular stent thrombosis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Vertebrobasilar stroke | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Epitaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Alcoholic pancreatitis | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Helicobacter gastritis | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Intestinal mass | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Biliary dilatation | Hepatobiliary disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Gout | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Stress urinary incontinence | Renal and urinary disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Genital prolapse | Reproductive system and breast disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Phimosis | Reproductive system and breast disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Scrotal haematoma | Reproductive system and breast disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Ureteroscopy | Investigations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Atheroembolism | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Delayed recovery from anaesthesia | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Elastic vessel recoil complication | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Implant site infection | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Post procedural hypotension | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Vascular access site haematoma | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Vascular procedure complication | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Aortic aneurysm repair | Surgical and medical procedures | MedDRA (23.0) | Non-systematic Assessment |
| |
| Aortic valve replacement | Surgical and medical procedures | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cardiac ablation | Surgical and medical procedures | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA (23.0) | Non-systematic Assessment |
| |
| Device breakage | Product Issues | MedDRA (23.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Peripheral artery dissection | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Peripheral artery restenosis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Birgit Greschner | Shockwave Medical | 650-575-6199 | bgreschner@shockwavemedical.com |
| Mar 23, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Austria |
|
| United States |
|
| Germany |
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| Medtronic IN.PACT (DCB) |
Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| Medtronic IN.PACT (DCB) |
Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|
| OG001 | Medtronic IN.PACT (DCB) | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Medtronic IN.PACT (DCB): The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. |
|
|