NCT03421561已完成不适用
ProspectIve, Randomized, SingLe-Blind, U.S. MuLti-Center Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon Pivotal Post-Approval Study
Spectranetics Corporation41 个研究点 分布在 2 个国家目标入组 300 人开始时间: 2013年6月18日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 41
- 主要终点
- Number of Participants With Freedom From Device and Procedure Related Death Through 30 Days Post-procedure and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization Through 24 Months Post-procedure
研究概览
简要总结
The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal pre-market study to evaluate the Stellarex DCB compared to the PTA control device for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.
详细描述
The objective of this continued follow-up of ILLUMENATE Pivotal Study subjects is to demonstrate the long term safety and effectiveness of the Stellarex DCB.
Each enrolled subject will be followed for 5 years (60 months) after treatment. A follow-up office visit will occur at 24 and 36 months. A follow-up telephone contact or an optional office visit will occur at 48 and 60 months.
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
- Double (Participant, 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
- •From ILLUMENATE Pivotal IDE population TP-1397E
- •Study subjects must fulfill the following clinical criteria:
- •Symptomatic leg ischemia, requiring treatment of the superficial femoral artery (SFA) and/or popliteal artery.
- •Greater than or equal to 18 years of age.
- •Willing to provide written informed consent, and capable and willing to comply with all required follow-up evaluations within the defined follow-up visit windows.
- •Will not undergo other planned vascular interventions within 14 days before and/or 30 days after the protocol treatment (successful treatment of ipsilateral and contralateral iliac permitted prior to enrollment).
- •Life expectancy >1 year.
- •Rutherford-Becker classification of 2, 3 or
- •Study Subjects must fulfill the following angiographic criteria:
- •De novo or restenotic lesion (except for in-stent restenotic lesion) >70% within the SFA and/or popliteal artery in a single limb.
- •Single lesion which is ≥3 cm and ≤18cm in length (by visual estimation). NOTE: Tandem lesions can be treated. A tandem lesion is defined as two distinct lesions with 3 cm or less of healthy vessel separating the two diseased areas. The total cumulative length of the tandem lesions, including the healthy vessel, must not exceed 18 cm.
- •Lesion is treatable by no more than two (2) study devices.
- •Successful wire crossing of the lesion. The guidewire advancement should not be indicative of the presence of fresh thrombus in the lesion.
- •Target reference vessel diameter is ≥4 mm and ≤6 mm (by visual estimation).
- •Inflow artery is patent, free from significant lesion stenosis (≥50% stenosis is considered significant) as confirmed by angiography. Treatment of a target lesion is acceptable after successful treatment of inflow artery lesion(s). NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis <30% without death or major vascular complication.
- •Target limb with at least one patent (less than 50% stenosis) tibio-peroneal run-off vessel confirmed by baseline angiography or prior magnetic resonance (MR) angiography or computed tomography (CT) angiography (within 45 days prior to index procedure). NOTE: treatment of outflow disease is NOT permitted.
排除标准
- •Subject with any of the following clinical criteria should be excluded:
- •Females who are pregnant, lactating, or intend to become pregnant, or males who intend to father children during study participation.
- •Known aortic aneurysm(s) > 5 cm.
- •Contraindication to dual anti-platelet therapy.
- •Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.
- •Current participation in an investigational drug or another device study.
- •History of hemorrhagic stroke within 3 months.
- •Previous or planned surgical or interventional procedure within 14 days before or 30 days after the index procedure (successful treatment of ipsilateral and contralateral iliac permitted prior to enrollment).
- •Prior endovascular treatment of target lesion by percutaneous transluminal angioplasty or any other means of previous endovascular treatment (e.g. stents/stent grafts, cutting balloon, scoring balloon, cryoplasty, thrombectomy, atherectomy, brachytherapy or laser devices) within six months of the index procedure, or any previous placement of a bypass graft proximal to the target lesion.
- •Treatment of lesions in the contralateral limb with the CVI Paclitaxel-coated PTA Catheter.
- •Use of the CVI Paclitaxel-coated PTA Catheter in other than a single treatment session.
- •Chronic renal insufficiency (dialysis dependent, or serum creatinine >2.5 mg/dL within 30 days of index procedure).
- •Subject with any of the following angiographic criteria should be excluded:
- •Significant contralateral or ipsilateral common femoral disease that requires intervention during the index procedure.
- •No normal proximal arterial segment of the target vessel in which duplex ultrasound velocity ratios can be measured.
- •Known inadequate distal outflow.
- •Acute or sub-acute thrombus in the target vessel.
- •Aneurysmal target vessel.
- •Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy) during the index procedure in the target lesion or target vessel.
- •Treatment of the contralateral limb during the same procedure or within 30 days following the study procedure (exclusive of the iliac arteries which can be treated prior to enrollment).
- •Presence of concentric calcification that precludes PTA pre-dilation.
- •Prior stent placement in the target vessel.
- •Residual stenosis of greater than 70%, stent placement or flow-limiting (Grade D or greater) dissection following pre-dilation.
研究组 & 干预措施
DCB Subjects
Experimental
The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.
Basic Catheter Specifications
- Guidewire: 0.035"
- Balloon Length: 40/80/120 mm
- Sheath Compatibility: greater than or equal to 6 French
- Balloon Diameter: 4/5/6 mm
- Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.
干预措施: Stellarex 0.035" OTW Drug-coated Angioplasty Balloon (Device)
PTA Subjects
Placebo Comparator
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Basic Catheter Specifications
- Guidewire: 0.035"
- Balloon Length: 40/80/120 mm
- Sheath Compatibility: greater to or equal to 6 French
- Balloon Diameter: 4/5/6 mm
- Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.
干预措施: EverCross™ 0.035 PTA Balloon Catheter (Device)
结局指标
主要结局
Number of Participants With Freedom From Device and Procedure Related Death Through 30 Days Post-procedure and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization Through 24 Months Post-procedure
时间窗: 24 months post-procedure
The primary safety outcome is defined as freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 24 months post-procedure (defined as 730 ± 45 days, i.e., up to 775 days).
Number of Participants With Target Vessel Patency at 24 Months Post-procedure
时间窗: 24 months post-procedure
Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.
次要结局
- Major Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)(36 months post-procedure)
- Major Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)(48 months post-procedure)
- Major Adverse Event (MAE) Rate at 60 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)(60 months post-procedure)
- Rate of Clinically-driven Target Lesion Revascularization(60 months post-procedure)
- Rate of Target Lesion Revascularization(60 months post-procedure)
- Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR(36 months post-procedure)
- Mortality Rate(60 months post-procedure)
- Change in Ankle-brachial Index (ABI) From Pre-procedure(36 months post-procedure)
- Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure(36 months post-procedure)
- Change in Rutherford-Becker Classification From Pre-procedure(36 months post-procedure)
- Change in EQ-5D VAS From Pre-procedure(36 month post procedure)
- Rate of Target Limb Major Amputation(60 months post-procedure)
- Major Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)(24 months post-procedure)
- Change in Walking Distance From Pre-procedure(36 months post-procedure)
- Change in EQ-5D Index From Pre-procedure(36 months post-procedure)
- Rate of Clinically-driven Target Vessel Revascularization(60 months post-procedure)
- Rate of Occurrence of Arterial Thrombosis of the Treated Segment(60 months post-procedure)
- Rate of Clinically-driven Target Lesion Revascularization(24 months post-procedure)
- Rate of Clinically-driven Target Lesion Revascularization(36 months post-procedure)
- Rate of Clinically-driven Target Lesion Revascularization(48 months post-procedure)
- Rate of Target Lesion Revascularization(24 months post-procedure)
- Mortality Rate(36 months post-procedure)
- Rate of Target Lesion Revascularization(36 months post-procedure)
- Rate of Target Lesion Revascularization(48 months post-procedure)
- Rate of Clinically-driven Target Vessel Revascularization(24 months post-procedure)
- Rate of Clinically-driven Target Vessel Revascularization(36 months post-procedure)
- Mortality Rate(48 months post-procedure)
- Rate of Clinically-driven Target Vessel Revascularization(48 months post-procedure)
- Rate of Target Limb Major Amputation(24 months post-procedure)
- Rate of Target Limb Major Amputation(36 months post-procedure)
- Rate of Target Limb Major Amputation(48 months post-procedure)
- Mortality Rate(24 months post-procedure)
- Rate of Occurrence of Arterial Thrombosis of the Treated Segment(24 months post-procedure)
- Rate of Occurrence of Arterial Thrombosis of the Treated Segment(36 months post-procedure)
- Rate of Occurrence of Arterial Thrombosis of the Treated Segment(48 months post-procedure)
- Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR(24 months post-procedure)
- Change in Ankle-brachial Index (ABI) From Pre-procedure(24 months post-procedure)
- Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure(24 months post-procedure)
- Change in Walking Distance From Pre-procedure(24 months post-procedure)
- Change in Rutherford-Becker Classification From Pre-procedure(24 months post-procedure)
- Change in EQ-5D Index From Pre-procedure(24 months post-procedure)
- Change in EQ-5D VAS From Pre-procedure(24 months post procedure)
研究者
研究点 (41)
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