BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multi-Center, Non-Randomized, Single-Arm Study of the BARD® LIFESTREAM™ Balloon Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease (BOLSTER)

Conditions
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Peripheral Artery Disease, Peripheral Vascular Disease, Arterial Occlusive Disease

Intervention / Treatment
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* Procedure: Percutaneous transluminal angioplasty (PTA)
* Device: LIFESTREAM™ covered stent


Participation Criteria
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Eligibility Criteria
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CLINICAL INCLUSION CRITERIA: The subject provides written informed consent using an Informed Consent Form approved by the Ethics Committee/ Institutional Review Board for the site. Subject agrees to comply with the protocol-mandated follow-up procedures and visits. Subject is a male or non-pregnant female ≥ 21 years old with an expected lifespan sufficient to allow for completion of all study procedures. Subject has intermittent claudication (Rutherford Category 2-3) or ischemic rest pain (Rutherford Category 4). Subject is able and willing to comply with any required medication regimen. ANGIOGRAPHIC INCLUSION CRITERIA: Subject has evidence of single, bilateral, or multiple de novo and/or restenotic (non-stented) lesion in the native common and/or external iliac artery that is ≥ 50% stenosed (including total occlusions). The target lesion can be successfully crossed with a guide wire and pre-dilated with an appropriately sized PTA balloon. The reference vessel diameter is between 4.5 mm -12.0 mm in diameter. The target lesion is ≤ 100 mm in combined length (per side). The subject has angiographic evidence of a patent (< 50% stenosis) profunda and/or superficial femoral artery (SFA) in the target limb. CLINICAL EXCLUSION CRITERIA: The subject is unable or unwilling to provide written informed consent or to conform to the study protocol follow-up procedures and visits. The subject is or plans to become pregnant during the study. The subject is asymptomatic, has mild claudication or critical limb ischemia with tissue loss described as Rutherford Category 0, 1, 5 or 6. The subject has a vascular graft previously implanted in the native iliac vessel. The subject suffered a hemorrhagic stroke or transient ischemic attack (TIA) within 3 months prior to the index procedure. The subject has a known uncorrectable bleeding diathesis or active coagulopathy. The subject has a serum creatinine ≥ 2.5 mg/dl or is on dialysis. The subject has a known allergy or sensitivity to stainless steel (i.e., Nickel), ePTFE, or has intolerance to the antiplatelet, anticoagulant or thrombolytic medications required per the protocol. The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated. The subject had a prior vascular intervention within 30 days before or planned for within 30 days after the index procedure. The subject has another medical condition, which may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up. The subject is currently participating in an investigational drug, biologic, or another device study. ANGIOGRAPHIC EXCLUSION CRITERIA: The subject has extensive peripheral vascular disease, which in the opinion of the Investigator, would preclude safe insertion of an introducer sheath. The ipsilateral common femoral artery should be patent (< 50% stenosis). The target lesion requires treatment other than angioplasty to facilitate subject device delivery. The subject has severe calcification of the target lesion, preventing inflation of PTA balloon. The target lesion has been previously treated with a stent (bare or covered). The subject has angiographic evidence of acute thrombus at the target lesion. The target lesion involves the origin of the internal iliac artery such that successful treatment of the lesion would require the subject device to cross/occlude the side branch. The target lesion located in the distal external iliac artery such that successful treatment of the lesion would require the subject device to cross/occlude side branches or be exposed to compressive forces associated with the close proximity to the common femoral artery. The subject has an abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion. The subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery prior to the initiation of the treatment for this study.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIFESTREAM™<br>This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent. | Procedure: Percutaneous transluminal angioplasty (PTA)<br>* Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.<br>Device: LIFESTREAM™ covered stent<br>* Implantation of the LIFESTREAM™ covered stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 9 months post index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Major Adverse Events (MAEs) Through 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. | 9 months post index procedure | 
| Number of Lesions With Acute Lesion Success | 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. | At time of Index Procedure | 
| Number of Participants With Acute Procedure Success | 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. | At time of hospital discharge | 
| Number of Devices With Acute Technical Success at Index Procedure | Acute Technical Success defined as successful deployment of the LIFESTREAM™ Covered Stent at the intended location, as determined by the Investigator. | At time of index procedure | 
| Number of Participants With Target Lesion Revascularization (TLR) at 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. | 6, 9, 12, 24, and 36 months post index procedure | 
| Number of Participants With Target Vessel Revascularization (TVR) Event at 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. | 6, 9, 12, 24, and 36 months post index procedure | 
| Number of Participants With Sustained Clinical Success at 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. | 30 days, and 9, 12, 24, and 36 months post index procedure | 
| Number of Participants With Primary Patency at 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. | 9, 12, 24 and 36 months post index procedure | 
| Number of Participants With Assisted Primary Patency at 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. | 9, 12, 24, and 36 months post index procedure | 
| Number of Participants With Secondary Patency at 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. | 9,12, 24, and 36 months post index procedure | 
| Change in Walking Impairment Questionnaire (WIQ) Scores at 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. | 30 Days, 9, 12, 24, and 36 months post index procedure compared to baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lack of perfusion in the extremities, Atherosclerosis, Intermittent claudication, BOLSTER