NCT02963649已完成不适用
Randomized Study of IN.PACT 014 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter vs. Optimal Percutaneous Transluminal Angioplasty for the Treatment of Chronic Total Occlusions in the Infrapopliteal Arteries
Medtronic Endovascular17 个研究点 分布在 5 个国家目标入组 50 人开始时间: 2017年3月2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
- 50
- 试验地点
- 17
- 主要终点
- Primary Effectiveness Endpoint: Late Lumen Loss (LLL) at 9 Months
研究概览
简要总结
To assess the safety and efficacy of the paclitaxel drug-coated balloon IN.PACT 014 versus conventional optimal percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the infrapopliteal arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Subject has been informed of the nature of the study, agrees to participate and has signed an EC approved consent form.
- •Female subjects of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation.
- •Subject has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Clinical Category 4 or
- •Subjects with documented infection grade 0-2 and ischemia grade 2-3 according to WIfi classification.
- •Life expectancy >1 year in the Investigator's opinion.
- •Reference Vessel Diameter (RVD) 2 - 4 mm, and confirmed by DUS assessment.
- •Total occlusions with total lesion length ≥ 40 mm (by visual estimate).
- •Lesion must be located in the infrapopliteal arteries and above the ankle joint.
- •Multiple lesions can be treated if located in separate vessels.
- •Presence of documented run-off to the foot.
- •Inflow free from flow-limiting lesion confirmed by angiography.
- •Successful pre-dilatation of the (entire) target lesion.
排除标准
- •Subject unwilling or unlikely to comply to the appropriate follow-up times for the duration of the study.
- •Planned index limb amputation above the metatarsal level, or any other planned major surgery within 30 days pre or post-procedure.
- •Lesion and/or occlusions located or extending in the popliteal artery or below the ankle joint space.
- •Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral iliac, SFA and popliteal arteries left untreated.
- •Failure to obtain ≤ 30% residual stenosis in pre-existing, hemodynamically significant inflow lesions in the ipsilateral iliac, SFA and popliteal artery.
- •Prior stent(s) or bypass surgery within the target vessel(s) (including stents placed within target vessels during the index procedure prior to randomization.
- •Previous DCB procedure in the target vessel within 6 months prior to index procedure.
- •Aneurysm in the target vessel.
- •Angiographic evidence of thrombus within target limb.
- •Pre-dilatation resulted in major (≥ Grade D) flow-limiting dissection or residual stenosis > 30%.
- •Use of alternative therapy e.g. atherectomy, cutting balloon, laser, radiation therapy, stents as part of target vessel treatment.
- •Recent MI or stroke < 30 days prior to the index procedure.
- •Heart failure with Ejection Fraction < 30%.
- •Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound on the target limb.
- •Subjects with infection grade 3 and ischemia grade 0 and 1 according to the Wifi classification.
- •Subjects with neutrotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk of major amputation.
- •Subjects with documented active osteomyelitis, excluding the phalanges, that is beyond cortical involvement of the bone per clinical judgement.
- •Impaired renal function (GFR <20 mL/min) and patients on dialysis.
- •Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica on active treatment.
- •Patient receiving systemic corticosteroid therapy.
- •Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/anti-platelet therapies which could not be substituted, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
- •The patient is currently enrolled in another investigational device or drug trial that is interfering with the endpoints of this study.
- •Female subjects who are breastfeeding at the time of enrollment.
结局指标
主要结局
Primary Effectiveness Endpoint: Late Lumen Loss (LLL) at 9 Months
时间窗: 9 Months
Late lumen loss (LLL) - The difference between minimum lumen diameter (MLD) immediately after percutaneous balloon angioplasty PTA and MLD at follow up, measured at 9 months
次要结局
- Composite Safety Endpoint(9 Months)
- Major Adverse Event (MAE) Rate(through 3, 6, 9, 12, 24, 36, 48 and 60 months)
- Functional Flow Assessment(at 3, 6, 9, 12, 24 and 36 months)
- Death of Any Cause(through 3, 6, 9, 12, 24, 36, 48 and 60 months)
- Major Target Limb Amputation Rate(through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months)
- Target Lesion Revascularization (TLR) Rate(through 3, 6, 9, 12, 24, 36, 48 and 60 months)
- Clinically-driven Target Lesion Revascularization (CD-TLR) Rate(through 3, 6, 9, 12, 24, 36, 48 and 60 months)
- Mechanically-driven Target Lesion Revascularization (TLR) Rate(through 37 days)
- Clinically-driven Target Vessel Revascularization (CD-TVR) Rate(through 3, 6, 9, 12, 24, 36, 48 and 60 months)
- Target Vessel Revascularization (TVR) Rate(through 3, 6, 9, 12, 24, 36, 48 and 60 months)
- Status of Wound Healing(at 30 days, 3, 6, 9, 12, 24 and 36 months)
- Rate of Thrombosis at the Target Lesion(through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months)
- Device Success(at the time of procedure)
- Clinical Success(up to discharge visit [between index procedure and 30-day (+/- 7 days) follow-up visit. The average days until discharge was: 9 days (with a max. of 31days) in the IN.PACT 014 arm, and 6 days (with a max. of 21days) in the PTA arm.])
研究者
研究点 (17)
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