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The objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB PTA Catheter in a heterogeneous patient population in a real world and on-label clinical application.
The registry is a prospective, multicenter, single arm post-market real-world registry in the U.S. assessing the clinical use, safety and outcomes of the Lutonix 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA). Registry subjects will be followed for up to three year's post-index procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTA (Lutonix® 035 DCB Catheter) | Experimental | Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTA (Lutonix® 035 DCB Catheter) | Device | Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough. The Lutonix® DCB through the blood vessel to the narrowed area to be treated. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 12 Months Post Index Procedure | TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure. | 12 months post-index procedure |
| Percentage of Participants With Freedom From Composite of Device and/or Procedure Related Perioperative Death, Target Limb Major Amputation (Above the Ankle), and Target Vessel Revascularization) at 30 Days Post Index Procedure | Freedom from composite of device and/or procedure related perioperative (≤30 day) death, target limb major amputation (above the ankle), and target vessel revascularization. | 30 days post index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure | TVR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, surgical bypass, etc.) in the target vessel after the index procedure (Kaplan-Meier estimates). | 6 , 12, 24, and 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Shammas, MD | Midwest Cardiovascular Research Foundation | Principal Investigator |
| Edward Woo, MD | MedStar Regional | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lake Martin Laser and Vein Institute | Alexander City | Alabama | 35010 | United States | ||
| Chandler Regional Medical Center |
Between 2015 and 2017, Investigators treated 1005 subjects with the study device. Due to major protocol deviations, 39 subjects were excluded from the analyses conducted in this study. Therefore, the Per-Protocol population included 966 subjects and all outcome results and baseline data are based on this Per-Protocol population.
Overall, 1005 subjects were enrolled and treated with the study device. A total of 966 subjects were included in the Per-Protocol population (excludes subjects with major protocol deviations) for final analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | PTA (Lutonix® 035 DCB Catheter) | Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU. PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough. The Lutonix® DCB through the blood vessel to the narrowed area to be treated. |
| 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 | Aug 19, 2015 |
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|
| Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 24, and 36 Months Post Index Procedure. | TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure (Kapln-Meier estimates). | 6, 24, and 36 months post index procedure |
| Percentage of Participants With Acute Device and Procedural Success | Lesion success defined as attainment of < 30% residual stenosis of the target lesion after the index procedure using any percutaneous method and/or non-investigational device (i.e., post-dilatation) and no peri-procedural complications (death, stroke, MI, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge. | At time of Index Procedure |
| Percentage of Participants With Primary Patency at 12 Months Post Index Procedure | The absence of target lesion restenosis (defined by Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.5) and freedom from Target Lesion Revascularization (TLR). Primary Patency at 12-Months post index-procedure by Kaplan-Meier estimates using a Method in which all subjects without a confirmed TLR or loss of patency were censored at Day 395 or the date of study discontinuation, whichever occurred first. | 12 months post-index procedure |
| Percentage of Participants With Freedom From Composite of All-cause Perioperative (≤30 Day) Death and From the Following: Index Limb Amputation, Index Limb Reintervention, and Index-limb-related Death at 6, 12, 24, and 36 Months Post Index Procedure | Freedom from composite of all-cause perioperative (≤30 day) death and from the following: index limb amputation, index limb reintervention, and index-limb-related death (Kaplan-Meier estimates). | 6, 12, 24, and 36 Months Post Index Procedure |
| Percentage of Participants With Freedom From Major Amputation of the Target Limb (Above the Ankle Amputation) at 6, 12, 24, and 36 Months Post Index Procedure. | Freedom from major amputation of the target limb defined as above the ankle amputation | 6, 12, 24, and 36 Months Post Index Procedure |
| Chandler |
| Arizona |
| 85224 |
| United States |
| St. Luke's Hospital- Phoenix | Phoenix | Arizona | 85006 | United States |
| UCSD Health System | San Diego | California | 92093 | United States |
| Colorado Heart and Vascular | Lakewood | Colorado | 80228 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| MedStar Health Research Institute | Washington D.C. | District of Columbia | 20010 | United States |
| Research Physicians Network Alliance | Boynton Beach | Florida | 33435 | United States |
| Bradenton Cardiology Center | Bradenton | Florida | 34205 | United States |
| Clearwater Cardiovascular & Interventional Consultants | Clearwater | Florida | 33756 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32207 | United States |
| Sarah Cannon Research Institute, LLC | Jacksonville | Florida | 32216 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Orlando Health | Orlando | Florida | 32806 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northside Hospital, Inc | Atlanta | Georgia | 30342 | United States |
| Vascular Interventional of Thomasville, Associates | Thomasville | Georgia | 31792 | United States |
| Kaiser Foundation Hospitals | Honolulu | Hawaii | 96819 | United States |
| Peoria Radiology & Research Foundation | Peoria | Illinois | 61637 | United States |
| Prairie Education and Research Cooperative | Springfield | Illinois | 62701 | United States |
| Franciscan St. Francis Health | Indianapolis | Indiana | 46237 | United States |
| Midwest Cardiovascular Research Foundation | Davenport | Iowa | 52803 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Hutchinson Regional Medical Center - Hutchinson, Inc | Hutchinson | Kansas | 67502 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| MedStar Health Research Institute | Annapolis | Maryland | 21401 | United States |
| Cape Cod Research Institute | Hyannis | Massachusetts | 02601 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| St. John Hospital and Medical Center | Detroit | Michigan | 48236 | United States |
| Sparrow Clinical Research Institute | Lansing | Michigan | 48912 | United States |
| DLP Marquette General Hospital | Marquette | Michigan | 49855 | United States |
| Cardiac & Vascular Research Center of Northern Michigan/McLaren Northern Michigan Hospital | Petoskey | Michigan | 49770 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| Merit Health Wesley | Hattiesburg | Mississippi | 39402 | United States |
| Freeman Health System | Joplin | Missouri | 64804 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Cardiovascular Associates of Delaware Valley | Haddon Heights | New Jersey | 08035 | United States |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07754 | United States |
| New York Hospital-Queens | Flushing | New York | 11355 | United States |
| Mount Sinai Beth Israel | New York | New York | 10003 | United States |
| The Feinstein Institute for Medical Research | New York | New York | 10075 | United States |
| The Research Foundation for Suny | Syracuse | New York | 13210 | United States |
| CaroMont Heart Clinical Research | Gastonia | North Carolina | 28054 | United States |
| LeBauer Cardiovascular Research Foundation | Greensboro | North Carolina | 27401 | United States |
| Carolina East Health System | New Bern | North Carolina | 28562 | United States |
| Rex Hospital, Inc | Raleigh | North Carolina | 27607 | United States |
| Mercy West Hospital | Cincinnati | Ohio | 45211 | United States |
| Jobst Vascular Institute | Toledo | Ohio | 43603 | United States |
| Jane Phillips Memorial Medical Center | Bartlesville | Oklahoma | 74006 | United States |
| University of Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | United States |
| Integris Baptist Medical Center, Inc | Oklahoma City | Oklahoma | 73112 | United States |
| Providence Health & Service | Portland | Oregon | 97225 | United States |
| Lankenau Institute for Medical Research | Bryn Mawr | Pennsylvania | 19010 | United States |
| Saint Vincent Consultants in Cardiovascular Diseases | Erie | Pennsylvania | 16502 | United States |
| Heart Institute at Largo | Harrisburg | Pennsylvania | 17110 | United States |
| Allegheny-Singer Research Institute | Pittsburgh | Pennsylvania | 15212 | United States |
| Pinnacle Health Cardiovascular Institute | Wormleysburg | Pennsylvania | 17043 | United States |
| The Miriam Hospital - A Lifespan Partner | Providence | Rhode Island | 02906 | United States |
| Vascular Access Solutions | Orangeburg | South Carolina | 29118 | United States |
| Stern Cardiovascular Foundation, Inc | Germantown | Tennessee | 38138 | United States |
| Stern Cardiovascular Foundation Inc. | Memphis | Tennessee | 38120 | United States |
| Seton Heart Institute | Austin | Texas | 78705 | United States |
| Cardiovascular Specialists of Texas | Austin | Texas | 78758 | United States |
| Methodist Health System Clinical Research Institute | Dallas | Texas | 75203 | United States |
| El Paso Cardiology Associates, P.A. | El Paso | Texas | 79902 | United States |
| Houston Methodist Research Institute | Houston | Texas | 77030 | United States |
| Virginia Cardiovascular Specialists | Richmond | Virginia | 23225 | United States |
| Sentara Medical Group | Virginia Beach | Virginia | 23542 | United States |
| Lake Washington Vascular, PLLC | Bellevue | Washington | 98004 | United States |
| CAMC Health Education and Research Institute | Charleston | West Virginia | 25304 | United States |
| Bellin Memorial Hospital, Inc | Green Bay | Wisconsin | 54301 | United States |
| Wisconsin Heart-Meriter | Madison | Wisconsin | 53713 | United States |
| Columbia St. Mary's, Inc. | Milwaukee | Wisconsin | 53211 | United States |
| Per-Protocol Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Only Per-Protocol participants are included in the baseline measures.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PTA (Lutonix® 035 DCB Catheter) | Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU. PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough. The Lutonix® DCB through the blood vessel to the narrowed area to be treated. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Number of Target Lesions | Number | Participants |
| |||||||||||||||||||||||
| Number of Devices Used | 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 | Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 12 Months Post Index Procedure | TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure. | The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months post-index procedure |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Freedom From Composite of Device and/or Procedure Related Perioperative Death, Target Limb Major Amputation (Above the Ankle), and Target Vessel Revascularization) at 30 Days Post Index Procedure | Freedom from composite of device and/or procedure related perioperative (≤30 day) death, target limb major amputation (above the ankle), and target vessel revascularization. | The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 30 days post index procedure |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure | TVR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, surgical bypass, etc.) in the target vessel after the index procedure (Kaplan-Meier estimates). | The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 , 12, 24, and 36 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 24, and 36 Months Post Index Procedure. | TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure (Kapln-Meier estimates). | The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 6, 24, and 36 months post index procedure |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Acute Device and Procedural Success | Lesion success defined as attainment of < 30% residual stenosis of the target lesion after the index procedure using any percutaneous method and/or non-investigational device (i.e., post-dilatation) and no peri-procedural complications (death, stroke, MI, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge. | The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. | Posted | Number | 95% Confidence Interval | Percentage of Participants | At time of Index Procedure |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Primary Patency at 12 Months Post Index Procedure | The absence of target lesion restenosis (defined by Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.5) and freedom from Target Lesion Revascularization (TLR). Primary Patency at 12-Months post index-procedure by Kaplan-Meier estimates using a Method in which all subjects without a confirmed TLR or loss of patency were censored at Day 395 or the date of study discontinuation, whichever occurred first. | The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 months post-index procedure |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Freedom From Composite of All-cause Perioperative (≤30 Day) Death and From the Following: Index Limb Amputation, Index Limb Reintervention, and Index-limb-related Death at 6, 12, 24, and 36 Months Post Index Procedure | Freedom from composite of all-cause perioperative (≤30 day) death and from the following: index limb amputation, index limb reintervention, and index-limb-related death (Kaplan-Meier estimates). | The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 6, 12, 24, and 36 Months Post Index Procedure |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Freedom From Major Amputation of the Target Limb (Above the Ankle Amputation) at 6, 12, 24, and 36 Months Post Index Procedure. | Freedom from major amputation of the target limb defined as above the ankle amputation | The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 6, 12, 24, and 36 Months Post Index Procedure |
|
|
Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PTA (Lutonix® 035 DCB Catheter) | Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU. PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough. The Lutonix® DCB through the blood vessel to the narrowed area to be treated. | 173 | 1,005 | 65 | 1,005 | 121 | 1,005 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Retroperitoneal Haemorrhage | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vessel Puncture Site Haematoma | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Complication of Device removal | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Impaired Healing | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Thrombosis in Device | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Contrast Media Allergy | Immune system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Vessel Puncture Site Infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Peripheral Artery Restenosis | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Procedural Complication | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Peripheral Artery Dissection | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vessel Perforation | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Embolism Arterial | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Peripheral Artery Stenosis | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Peripheral Artery Thrombosis | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vasospasm | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Retroperitoneal Hemorrhage | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vessel Puncture Site Hematoma | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Local Swelling | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vessel Puncture Site Hemorrhage | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vessel Puncture Site swelling | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Complication of Device Removal | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Thrombosis in device | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vessel Puncture Site Pain | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Contrast Media Allergy | Immune system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Vessel Puncture Site Infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Peripheral Artery Restenosis | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Procedural Complication | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Scrotal Haematoma | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Skin Exfoliation | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Peripheral Artery Dissection | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vessel Perforation | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Peripheral Artery Stenosis | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Peripheral Artery Thrombosis | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Embolism Arterial | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Arteriovenous Fistula | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vasospasm | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Peripheral Artery Aneurysm | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharon Christensen | Becton Dickinson | 612-757-0750 | Sharon.Christensen@bd.com |
| Apr 29, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| D001157 | Arterial Occlusive Diseases |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 3 Target Lesions |
|
| 4 Target Lesions |
|
| 3 devices |
|
| 4 devices |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|