DRKS00006828已完成未知
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) - BOLSTER
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 154
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 21 Years 至 one（—）
- 性别
- All
入选标准
- •1. The subject provides written informed consent using an Informed
- •Consent Form (ICF) that is reviewed and approved by the Ethics
- •Committee (EC) / Institutional Review Board (IRB) for the site.
- •2. Subject agrees to comply with the protocol-mandated follow-up
- •procedures and visits.
- •3. The subject is a male or non-pregnant female = 21 years old with an
- •expected lifespan sufficient to allow for completion of all study
- •procedures. Female subjects of childbearing potential must have a
- •negative pregnancy test (urine or blood) within 14 days prior to the index
- •4. The subject has intermittent claudication (Rutherford Category 2-3) or
- •ischemic rest pain (Rutherford Category 4).
- •5. The subject is able and willing to comply with any required medication
- •6. The subject has evidence of single, bilateral, or multiple de novo and/or
- •restenotic (non-stented) lesion(s) in the native common and/or external
- •iliac artery that is (are) = 50% stenosed
- •7. The target lesion(s) can be successfully crossed with a guide wire and
- •pre-dilated with an appropriately sized PTA balloon. Devices such as
- •chronic total occlusion (CTO) catheters or re-entry devices may be used
- •to facilitate target lesion(s) crossing.
- •8. The reference vessel diameter(s) is (are) between 4.5 mm and 12.0 mm
- •in diameter as determined by the Investigator’s visual estimate.
- •9. The target lesion(s) is (are) = 100 mm in combined length (per side) as
- •determined by the Investigator’s visual estimate.
- •10. The subject has angiographic evidence of a patent (< 50% stenosis)
- •profunda and/or superficial femoral artery (SFA) in the target limb(s) as
- •determined by the Investigator’s visual estimate. Ipsilateral and
- •contralateral SFA lesions may be treated before or after target lesion
- •treatment, considering the following criteria are met:
- •- = 50% stenosis
- •- Stenosis(es) = 15cm in total length or a Total Occlusion = 5cm in
- •- = 1 vessel run-off
- •- No thrombus or severe calcification
- •- Use of on-Label devices
排除标准
- •1. The subject is unable or unwilling to provide written informed consent,
- •or is unable or unwilling to conform to the study protocol follow-up
- •procedures and visits.
- •2. The subject is or plans to become pregnant during the study.
- •3. The subject is asymptomatic, has mild claudication or critical limb
- •ischemia with tissue loss described as Rutherford Category 0
- •(asymptomatic), 1 (mild claudication), 5 (minor tissue loss), or 6 (major
- •tissue loss).
- •4. The subject has a vascular graft previously implanted in the native iliac
- •5. The subject suffered a hemorrhagic stroke or transient ischemic attack
- •(TIA) within 3 months prior to the index procedure.
- •6. The subject has a known uncorrectable bleeding diathesis or active
- •coagulopathy (platelet count < 80,000/µL).
- •7. The subject has a serum creatinine = 2.5 mg/dl or is currently on dialysis.
- •8. 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.
- •9. The subject has a known allergy or sensitivity to contrast media, which
- •cannot be adequately pre-medicated.
- •10. The subject had a prior vascular intervention(s) within 30 days before,
- •or has an intervention planned for within 30 days after the index
- •procedure. Refer to inclusion criterion #10 for exceptions on ipsilateral
- •SFA lesions and contralateral iliac and SFA lesions.
- •11. The subject has another medical condition, which, in the opinion of the
- •Investigator, 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 followup.
- •12. The subject is currently participating in an investigational drug,
- •biologic, or another device study.
- •13. The subject has extensive peripheral vascular disease, which in the
- •opinion of the Investigator, would preclude safe insertion of an introducer sheath (>50% Stenosis of common femoral artery)
- •14. The target lesion(s) requires treatment other than angioplasty (e.g.,
- •atherectomy, cryoplasty, cutting/scoring balloons, etc.) to facilitate
- •subject device delivery. Devices such as CTO catheters or re-entry
- •devices may be used to facilitate target lesion(s) crossing.
- •15. The subject has severe calcification of the target lesion(s), which
- •prevents inflation of a PTA balloon (pre-dilatation of the target lesion is
- •16. The target lesion(s) has been previously treated with a stent (bare or
- •covered). A target vessel(s) with a previously placed stent is permitted as
- •long as the subject device(s) will not come into contact with the
- •previously placed stent during treatment of the target lesion(s).
- •17. The subject has angiographic evidence of acute thrombus at the target
- •18. The target lesion(s) involves the origin of the internal iliac artery such
- •that successful treatment of the lesion(s) would require the subject
- •device(s) to cross/occlude the side branch. Note, if the internal iliac
- •artery is already occluded, the subject device(s) can be placed across the
- •occluded vessel.
- •19. The target lesion(s) is (are) located in the distal external iliac artery
- •such that successful treatment of the lesion(s) would require the subject
- •device(s) to cross/occlude side branches (inferior epigastric artery and/or
- 另有 1 项未显示
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