NCT02228564已完成不适用
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)
C. R. Bard39 个研究点 分布在 3 个国家目标入组 155 人开始时间: 2014年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 39
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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.
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
- Number of Participants With Major Adverse Events (MAEs) Through 9-Months Post Index Procedure.(9 months post index procedure)
- Number of Lesions With Acute Lesion Success(At time of Index Procedure)
- Number of Devices With Acute Technical Success at Index Procedure(At time of index procedure)
- Number of Participants With Acute Procedure Success(At time of 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)
- 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)
- 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)
- 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.)
研究者
研究点 (39)
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