Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective, multi-center, single-arm study of the M5+ Peripheral IVL system to treat calcified peripheral arteries.
The objective of this study is to assess the safety and performance of the Shockwave M5+ Peripheral IVL System to treat calcified peripheral arteries in pre-market countries, and to assess continued safety and effectiveness in the US. A minimum of 40 lesions in up to 40 subjects at up to 10 sites in Australia, New Zealand and the US will be enrolled with the aim of treating at least 20 target lesions with the 8.0 mm IVL catheter. A maximum of three target lesions may be treated per subject. Subjects with moderate and severely calcified iliac and femoropopliteal artery disease presenting with Rutherford Category 2 to 5. Approximately 6 months of enrollment at up to 10 sites in Australia, New Zealand and the US. Study subjects will be followed through discharge, 30 days, 6 and 12 months. Duplex Ultrasound (DUS) assessments will be completed at 12 months. Total anticipated study duration is 18 months. The primary safety endpoint is Major Adverse Events (MAE) at 30 days defined as: need for emergency surgical revascularization of target limb; unplanned target limb major amputation (above the ankle); symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization ; or perforations that require an intervention, including bail-out stenting. The primary performance endpoint is technical success defined as final residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion by angiographic core lab.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) | Device | The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Adverse Events (MAE) | Defined as: Need for emergency surgical revascularization of target limb
| 30 days |
| Number of Lesions With Technical Success | Defined as final residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion by angiographic core lab. | Peri-procedural, approximately 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Lesions With IVL Technical Success | Defined as residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion post-IVL by angiographic core lab | Peri-procedural, approximately 2 hours |
| Number of Participants With Procedural Success |
Not provided
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 > 18.
Rutherford Clinical Category 2, 3, 4 or 5 of the target limb(s).
Estimated life expectancy >1 year.
Subject is intended to undergo treatment with Shockwave M5+ Peripheral IVL System for de novo lesions of the ilio-femoropopliteal arteries.
Angiographic Inclusion Criteria
Single or multiple de novo target lesion(s) located from the common iliac to the femoropopliteal artery, in one or both limbs.
Target lesion reference vessel diameter is between 3.5mm and 8.0mm by visual estimate.
Target lesion is ≥70% stenosis by investigator via visual estimate.
Target lesion length is ≤200mm for lesions 70-99% stenosed. Target lesion can be all or part of the 200mm treated zone.
Chronic total occlusion, lesion length is ≤100mm of the total ≤200 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, and 6.
Subject has active infection requiring antibiotic therapy.
History of endovascular or surgical procedure on the target limb within the last 30 days or planned within 30 days of the index procedure. Note: Concomitant IVL treatment to facilitate large bore access at the time of procedure is allowed.
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.
Subject has acute or chronic renal disease defined as serum creatinine of >2.5 mg/dL or >220 umol/L, unless 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 planned use of specialty balloons, re-entry or atherectomy devices in the target lesion(s).
Angiographic Exclusion Criteria
In-stent restenosis within 10mm of the target zone.
Target lesions distal to the popliteal 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 more than three target lesions requiring treatment.
Subject has significant non-target lesion (>50% stenosis or occlusion) within the target limb (e.g. iliac, common femoral or below-the-knee) not successfully treated prior to treatment of the target lesions.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Cardiovascular Research Foundation | Davenport | Iowa | 52803 | United States | ||
| NC Heart and Vascular Research |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) | Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Apr 27, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Defined as final residual stenosis ≤30% without any flow-limiting dissection (≥ Grade D) in all target lesions by angiographic core lab |
| Peri-procedural, approximately 2 hours |
| Number of Participants With Clinically-driven Target Lesion Revascularization (TLR) | A target lesion revascularization performed due to target lesion diameter stenosis ≥50% and either evidence of clinical or functional ischemia (e.g., recurrent/progressive life-limiting intermittent claudication, claudication unresponsive to medical therapy, CLI) or recurrence of the clinical syndrome for which the initial procedure was performed. Clinically driven target lesion revascularization occurs in the absence of protocol directed surveillance ultrasound or angiography. | 30 days |
| Rutherford Category Reported as Change From Baseline | Number of Participants with Improvement in Rutherford Score from as reported at 30 days post-procedure | 30 days |
| Number of Participants With Major Adverse Events (MAE) |
| 6 months |
| Number of Participants With Clinically-driven Target Lesion Revascularization (TLR) | A target lesion revascularization performed due to target lesion diameter stenosis ≥50% and either evidence of clinical or functional ischemia (e.g., recurrent/progressive life-limiting intermittent claudication, claudication unresponsive to medical therapy, CLI) or recurrence of the clinical syndrome for which the initial procedure was performed. Clinically driven target lesion revascularization occurs in the absence of protocol directed surveillance ultrasound or angiography. | 6 months |
| Rutherford Category Reported as Change From Baseline | Number of Participants with Improvement in Rutherford Score from as reported at 6 months post-procedure | 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 ≥50% stenosis | 12 months |
| Number of Participants With Major Adverse Events (MAE) |
| 12 months |
| Number of Participants With Clinically-driven Target Lesion Revascularization (TLR) | A target lesion revascularization performed due to target lesion diameter stenosis ≥50% and either evidence of clinical or functional ischemia (e.g., recurrent/progressive life-limiting intermittent claudication, claudication unresponsive to medical therapy, CLI) or recurrence of the clinical syndrome for which the initial procedure was performed. Clinically driven target lesion revascularization occurs in the absence of protocol directed surveillance ultrasound or angiography. | 12 months |
| Ankle-brachial Index (ABI) Reported as Change From Baseline | ABI at 12 months reported 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 |
| Rutherford Category Reported as Change From Baseline | Number of Participants with Improvement in Rutherford Score from as reported at 12 Months post-procedure. | 12 months |
| Raleigh |
| North Carolina |
| 27607 |
| United States |
| St. John Clinic | Bartlesville | Oklahoma | 74006 | United States |
| Prince of Wales Hospital | Randwick | New South Wales | 2031 | Australia |
| Perth Institute of Vascular Research | Nedlands | Western Australia | 6009 | Australia |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Christchurch Hospital | Christchurch | 8011 | New Zealand |
| Waikato District Hospital | Hamilton | 3204 | New Zealand |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries. |
| 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 | Number | 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 Major Adverse Events (MAE) | Defined as: Need for emergency surgical revascularization of target limb
| Posted | Count of Participants | Participants | 30 days |
|
|
| |||||||||||||||||||||||||||
| Primary | Number of Lesions With Technical Success | Defined as final residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion by angiographic core lab. | Technical success is on a per lesion basis, not per subject. | Posted | Count of Units | Lesions | Peri-procedural, approximately 2 hours | Lesions | Lesions |
|
| |||||||||||||||||||||||||
| Secondary | Number of Lesions With IVL Technical Success | Defined as residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion post-IVL by angiographic core lab | IVL Technical Success was calculated on a per lesion basis, not per subject. | Posted | Count of Units | Lesions | Peri-procedural, approximately 2 hours | Lesions | Lesions |
|
| |||||||||||||||||||||||||
| Secondary | Number of Participants With Procedural Success | Defined as final residual stenosis ≤30% without any flow-limiting dissection (≥ Grade D) in all target lesions by angiographic core lab | Posted | Count of Participants | Participants | Peri-procedural, approximately 2 hours |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically-driven Target Lesion Revascularization (TLR) | A target lesion revascularization performed due to target lesion diameter stenosis ≥50% and either evidence of clinical or functional ischemia (e.g., recurrent/progressive life-limiting intermittent claudication, claudication unresponsive to medical therapy, CLI) or recurrence of the clinical syndrome for which the initial procedure was performed. Clinically driven target lesion revascularization occurs in the absence of protocol directed surveillance ultrasound or angiography. | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||
| Secondary | Rutherford Category Reported as Change From Baseline | Number of Participants with Improvement in Rutherford Score from as reported at 30 days post-procedure | Improved from baseline | Posted | Count of Participants | Participants | 30 days |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Adverse Events (MAE) |
| Posted | Count of Participants | Participants | 6 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically-driven Target Lesion Revascularization (TLR) | A target lesion revascularization performed due to target lesion diameter stenosis ≥50% and either evidence of clinical or functional ischemia (e.g., recurrent/progressive life-limiting intermittent claudication, claudication unresponsive to medical therapy, CLI) or recurrence of the clinical syndrome for which the initial procedure was performed. Clinically driven target lesion revascularization occurs in the absence of protocol directed surveillance ultrasound or angiography. | Posted | Count of Participants | Participants | 6 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Rutherford Category Reported as Change From Baseline | Number of Participants with Improvement in Rutherford Score from as reported at 6 months post-procedure | Improved from baseline | Posted | Count of Participants | Participants | 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 ≥50% stenosis | Posted | Count of Participants | Participants | 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Adverse Events (MAE) |
| Posted | Count of Participants | Participants | 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically-driven Target Lesion Revascularization (TLR) | A target lesion revascularization performed due to target lesion diameter stenosis ≥50% and either evidence of clinical or functional ischemia (e.g., recurrent/progressive life-limiting intermittent claudication, claudication unresponsive to medical therapy, CLI) or recurrence of the clinical syndrome for which the initial procedure was performed. Clinically driven target lesion revascularization occurs in the absence of protocol directed surveillance ultrasound or angiography. | Posted | Count of Participants | Participants | 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Ankle-brachial Index (ABI) Reported as Change From Baseline | ABI at 12 months reported 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 | ratio | 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Rutherford Category Reported as Change From Baseline | Number of Participants with Improvement in Rutherford Score from as reported at 12 Months post-procedure. | Improved from baseline | Posted | Count of Participants | Participants | 12 months |
|
|
This accounting is for all study events through the 12 month time frame.
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 | Single Arm | Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL): The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries. | 1 | 37 | 20 | 37 | 36 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Pulmonary oedema | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Upper gastroinstestinal haemorrhage | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Complication of device removal | General disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
| |
| Nephropathy toxic | Injury, poisoning and procedural complications | MedDRA (21.1) | Non-systematic Assessment |
| |
| Vascular access site occlusion | Injury, poisoning and procedural complications | MedDRA (21.1) | Non-systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (21.1) | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Non-systematic Assessment |
| |
| Non-small cell lung cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Non-systematic Assessment |
| |
| Skin squamous cell carcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Leg amputation | Surgical and medical procedures | MedDRA (21.1) | Non-systematic Assessment |
| |
| Rehabilitation therapy | Surgical and medical procedures | MedDRA (21.1) | Non-systematic Assessment |
| |
| Arterial bypass stenosis | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Blue toe syndrome | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (21.1) | 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 stenosis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Retroperitoneal haemorrhage | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Venous ulcer pain | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (21.1) | Non-systematic Assessment |
| |
| Vascular access site haematoma | Injury, poisoning and procedural complications | MedDRA (21.1) | Non-systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (21.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Iliac artery dissection | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Peripheral artery restenosis | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Peripheral artery dissection | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Ischemic rest pain | Vascular disorders | MedDRA (21.1) | 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 |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Australia |
|
| Lesions |
|
|
| Lesions |
|
|
|
|
|
|
|
|
|
|
|
|
|