BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease
- Conditions
- Peripheral Artery DiseasePeripheral Vascular DiseaseArterial Occlusive Disease
- Interventions
- Procedure: Percutaneous transluminal angioplasty (PTA)Device: LIFESTREAM™ covered stent
- Registration Number
- NCT02228564
- Lead Sponsor
- C. R. Bard
- Brief Summary
Collect confirmatory evidence of the safety and effectiveness of the Balloon LIFESTREAM™ Stent Graft for the treatment of stenoses and occlusion in the iliac arteries.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LIFESTREAM™ Percutaneous transluminal angioplasty (PTA) This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent. LIFESTREAM™ LIFESTREAM™ covered stent This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
- Primary Outcome Measures
Name Time Method Number of Participants With Device and/or Procedure-Related Death or Myocardial Infarction (MI) Through 30 Days, or Any Target Lesion Revascularization (TLR), Target Limb(s) Major Amputation, or Restenosis Through 9-Months Post Index Procedure. 9 months post index procedure The primary endpoint is a composite safety and effectiveness measure defined as device and/or procedure-related death or myocardial infarction (MI) through 30 days, or any Target Lesion Revascularization (TLR), target limb(s) major amputation, or restenosis through 9-months post-index procedure.
- Secondary Outcome Measures
Name Time Method Number of Participants With Target Lesion Revascularization (TLR) at 6, 9, 12, 24, and 36 Months Post Index Procedure 6, 9, 12, 24, and 36 months post index procedure Target Lesion Revascularization (TLR) is defined as the first revascularization procedure (e.g., PTA, atherectomy, etc.) of the target lesion(s) following the index procedure, as determined by an Independent Angiographic Core Lab. All Target Lesion Revascularizations (TLR) were Target Vessel Revascularizations (TVR) and therefore, the results presented in Outcome #6 and Outcome #7 are the same.
Number of Participants With Target Vessel Revascularization (TVR) Event at 6, 9, 12, 24, and 36 Months Post Index Procedure. 6, 9, 12, 24, and 36 months post index procedure Target Vessel Revascularization (TVR) is defined as the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in the target vessel(s) following the index procedure, as determined by an Independent Angiographic Core Lab. All Target Vessel Revascularizations (TVR) were Target Lesion Revascularizations (TLR) and therefore, the results presented in Outcome #6 and Outcome #7 are the same.
Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure 9, 12, 24 and 36 months post index procedure Primary Patency at 9, 12, 24 and 36-months post-index procedure corresponding to PSVR ≤ 2.4.
Number of Participants With Major Adverse Events (MAEs) Through 9-Months Post Index Procedure. 9 months post index procedure Major Adverse Events (MAE) defined as device and/or procedure-related death or MI through 30 days, or any TLR or target limb(s) major amputation through 9-months post-index procedure. Major amputation is defined as an amputation at or above the ankle.
Number of Lesions With Acute Lesion Success At time of Index Procedure Acute 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), as determined by an Independent Angiographic Core Lab.
Number of Devices With Acute Technical Success at Index Procedure At time of index procedure Acute Technical Success defined as successful deployment of the LIFESTREAM™ Covered Stent at the intended location, as determined by the Investigator.
Number of Participants With Acute Procedure Success At time of hospital discharge Acute Procedure Success defined as lesion success and no peri-procedural complications (death, stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge.
Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure. 9,12, 24, and 36 months post index procedure Secondary Patency is a measure of success at re-establishing patency following failure of the initial stent placement due to stenosis or re-occlusion. In this study, Secondary Patency was independent of whether or not patency was re-established via an endovascular procedure following restenosis or occlusion, and was analyzed for the Intent to Treat (ITT) population. Secondary patency is defined as a peak systolic velocity ratio (PSVR) ≤ 2.4, as determined by an independent Duplex Ultrasonography (DUS) Core Lab.
Number of Participants With Assisted Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure 9, 12, 24, and 36 months post index procedure Primary Assisted Patency at 9-, 12-, 24-, and 36-months post-index procedure corresponding to PSVR ≤ 2.4, as determined by an Independent DUS Core Lab. Primary Assisted Patency is independent of whether or not patency is re-established via an endovascular procedure following restenosis.
Number of Participants With Sustained Clinical Success at 30-Days and 9, 12, 24, and 36 Months Post Index Procedure 30 days, and 9, 12, 24, and 36 months post index procedure Sustained Clinical Success defined as sustained cumulative improvement from baseline value of ≥ 1 Rutherford Category23 at 30-days and 9, 12, 24, and 36-months post-index procedure, as determined by the Investigator.
Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 9, 12, 24, and 36-Months Post Index Procedure Compared to Baseline. 30 Days, 9, 12, 24, and 36 months post index procedure compared to baseline. The WIQ assesses 3 categories of activities that include 1) walking distance, 2) stair-climbing, and 3) walking speed. Each question requires participants to rate their degree of difficulty with the activity on a scale of 0 (unable) to 4 (no problem). Final scores range from 0% to 100%, with lower percentages indicating higher levels of difficulties with activities.The results below represent the mean differences in total Walking Impairment Questionnaire (WIQ) scores at 30 days,9, 12, 24, and 36 months compared to baseline assessment scores.
Trial Locations
- Locations (20)
North Carolina Heart and Vascular
🇺🇸Raleigh, North Carolina, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Universitaetsklinikum Leipzig
🇩🇪Leipzig, Germany
Swedish Health Services
🇺🇸Seattle, Washington, United States
UC Davis Cardiovascular Medicine
🇺🇸Sacramento, California, United States
Donald Guthrie Foundation
🇺🇸Sayre, Pennsylvania, United States
Ev.Krankenhaus Königin Elisabeth
🇩🇪Berlin, Germany
Bonifatius Hospital
🇩🇪Lingen, Germany
Auckland Hospital
🇳🇿Auckland, New Zealand
CaroMont Regional Medical Center
🇺🇸Gastonia, North Carolina, United States
Florida Research Network
🇺🇸Gainesville, Florida, United States
Baptist Medical Center
🇺🇸Jacksonville, Florida, United States
Vascular and Interventional Specialists of Orange County
🇺🇸Orange, California, United States
University of Massachusetts Worcester
🇺🇸Worcester, Massachusetts, United States
Mount Sinai Medical Center
🇺🇸Miami, Florida, United States
Kansas City Vascular Foundation
🇺🇸Kansas City, Missouri, United States
Univeristy of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH
🇩🇪Bad Krozingen, Germany
Praxis fur Interventionelle Angiologie
🇩🇪Kaiserslautern, Germany
Lakeland Regional Medical Center
🇺🇸Lakeland, Florida, United States