RANGER II SFA: A 3:1 Randomized Trial Comparing the Boston Scientific RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty for the Treatment of Superficial Femoral Arteries (SFA) and Proximal Popliteal Arteries (PPA)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 440
- 试验地点
- 66
- 主要终点
- Number of Participants With Primary Lesion Patency
研究概览
简要总结
To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries (SFA/PPA).
Long Balloon substudy: To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) Ranger™ Paclitaxel Coated Balloon in the 120, 150 and 200 mm lengths for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions.
详细描述
The RANGER II SFA is a global, prospective, multi-center clinical trial. Approximately 446 subjects will be enrolled at up to 80 study centers worldwide. Regions participating include the United States, Canada, European Union, Japan and New Zealand.
The trial consists of a single-blind, superiority, 3:1 (Ranger Drug-Coated Balloon (DCB) vs. Standard PTA) randomized controlled trial (RCT) and a concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy, and a concurrent, non-blinded, non-randomized, Long balloon substudy.
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 (Participant)
盲法说明
Subjects will be blinded to treatment assigned and treatment received until completion of all 12 month follow-up visits (primary endpoint).
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject (or Legal Guardian) is willing and able to provide consent before any study-specific tests or procedures are performed and agree to attend all required follow-up visits;
- •Subject at least 20 years of age;
- •Chronic symptomatic lower limb ischemia defined as Rutherford classification 2, 3, or 4;
- •Target lesion is in the native SFA and/or PPA down to the P1 segment;
- •Patent popliteal and infrapopliteal arteries, i.e., single vessel runoff or better with at least one of three vessels patent (less than 50 % stenosis) to the ankle or foot;
- •Reference vessel diameter ≥ 4 mm and ≤ 8 mm by visual estimate;
- •Angiographic evidence that target lesion consists of a single de novo, non-stented and non-atherectomy treated or restenotic lesion (or tandem lesions or a combination lesion as defined below) that is:
- •≥ 70%-99% stenotic with total lesion length up to 180 mm by visual estimate.
- •Occluded with total lesion length ≤ 100 mm by visual estimate.
- •If lesion is restenotic, most recent PTA treatment must be > 3 months prior to enrollment.
排除标准
- •Life expectancy, documented in the Investigator's opinion, of less than 12 months;
- •Hemorrhagic stroke or cardiac event (e.g. STEMI, unstable angina) within 6 months prior to enrollment;
- •Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel;
- •Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated;
- •Chronic renal insufficiency with serum creatinine > 2.0 mg/dL within 30 days of index procedure or treatment with dialysis;
- •Platelet count < 80,000 mm 3 or > 600,000 mm 3 or history of bleeding diathesis;
- •Receiving immunosuppressive therapy;
- •Septicemia at the time of enrollment;
- •Any major intervention planned within 30 days post index procedure;
- •Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention within 30 days of enrollment;
- •Failure to successfully cross the target lesion with a guidewire;
- •Failure to successfully pre-dilate the target vessel;
- •Patient has lesion that requires the use of adjunctive primary treatment modalities (i.e. laser, atherectomy, scoring/cutting balloon, other debulking devices, etc.) during the index procedure;
- •History of major amputation in the target limb;
- •Target lesion or vessel has ever been previously treated with stent (e.g. in-stent restenosis) or surgery. Target lesion or vessel has been treated with atherectomy or a DCB in the past 12 months;
- •Pregnant or breast feeding;
- •Presence of aneurysm in the target vessel;
- •Acute ischemia and/or acute thrombosis of the SFA/PPA prior to enrollment;
- •Patient has significant inflow disease which cannot be treated prior to the target lesion treatment;
- •Patient has perforated targeted vessel as evidenced by extravasation of contrast media;
- •Patient has severe calcification that renders the lesion undilatable;
- •Current participation in another investigational drug or device clinical trial that has not completed the primary endpoint at the time of randomization/enrollment or that clinically interferes with the current trial endpoints.
研究组 & 干预措施
RANGER™ Paclitaxel Coated Balloon
RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
Subjects will be randomized 3:1 to the drug coated or standard angioplasty balloon.
干预措施: RANGER™ Paclitaxel Coated Balloon (Device)
RANGER™ Paclitaxel Coated Balloon
RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure.
Subjects will be randomized 3:1 to the drug coated or standard angioplasty balloon.
干预措施: Paclitaxel (Drug)
Standard Balloon Angioplasty
Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Subjects will be randomized 3:1 to the drug coated or standard angioplasty balloon.
干预措施: Standard Balloon Angioplasty (Procedure)
结局指标
主要结局
Number of Participants With Primary Lesion Patency
时间窗: 12 months (RCT); 6 months (LB substudy)
RCT outcome measure: Primary patency of the target lesion is determined by Peak Systolic Velocity Ratio (PSVR) ≤ 2.4 (by duplex ultrasound (DUS)) and freedom from clinically-driven Target Lesion Revascularization (TLR) within 12 months from procedure. Lesion patency is defined as freedom from more than 50% stenosis based on DUS PSVR comparing data within the treated segment to the proximal normal arterial segment. PSVR \>2.4 suggests \>50% stenosis. LB Substudy outcome measure: Primary patency of the target lesion is determined by duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≤ 2.4 in absence of clinically-driven TLR. Primary effectiveness endpoint is assessed at 6 months post-procedure. PK Substudy: There was no prespecified analysis of primary lesion patency.
Major Adverse Events (MAEs) (Primary Safety Endpoint)
时间窗: Primary safety endpoint assessed at 12 months for RCT study and at both 6 and 12 months for LB substudy.
RCT: MAE is defined as a composite of freedom from all-cause death through 1 month, target limb major amputation (defined as at or above the ankle) within 12 months, and/or Target Lesion Revascularization (TLR) within 12 months. LB Substudy: Primary safety endpoint assesses the occurrence of MAE defined as all-cause death through 1 month, target limb major amputation and/or TLR at 6 and 12 months post-index procedure. PK Substudy: There was no prespecified analysis of primary safety endpoint.
次要结局
- Number of Participants With Technical Success of Angioplasty Procedure(Day 0)
- Number of Participants With Procedural Success of Angioplasty Procedure(Day 0)
- Number of Participants With Clinical Success Rate Assessment(Day 0)
- Number of Major Adverse Event (MAE) Assessment(60-months (RCT); 12-months (LB substudy).)
- Number of Clinical Events Committee (CEC) Adjudicated Events(1, 6, 12, 24, 36, 48 and 60 months (RCT and PK substudy); 1, 6 and 12 months (LB substudy))
- Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline(1, 6, 12, 24 and 36 months post-procedure (RCT); 1, 6 and 12 months post-procedure (LB substudy).)
- Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline.(1, 6, 12, 24 and 36 months post-procedure (RCT): 1, 6, and 12 months post-procedure (LB substudy))
- Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline.(1, 6, 12, 24, and 36 months post-procedure (RCT); 1, 6, and 12 months post-procedure (LB substudy))
- Walking Improvement (Distance) at 6 and 12 Months as Assessed by Change in Six Minute Walk Test (6MWT) From Baseline(6 and 12 months post-procedure (RCT))
- Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline.(1, 6, 12, 24 and 36 months post-procedure (RCT))
- Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion(1, 6, 12, 24, and 36-months post-procedure (RCT); 1, 6, and 12-months post-procedure (LB substudy))
- Patient Utility Values as Assessed by Change in EQ-5D From Baseline.(1, 6, 12, 24 and 36-months post-procedure (RCT).)
- Changes in Healthcare Utilization Over Time(1, 6, 12, 24, 36, 48 and 60-months post-procedure (RCT); 1, 6, 12-months post-procedure (LB substudy))
- PK Parameters Paclitaxel (PTx) Dose(Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.)
- PK Parameters - Maximum Plasma Concentration(Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.)
- PK Parameters - Tmax(Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.)
- PK Parameters - Area Under the Blood Concentration Versus Time Curve From Time Zero up to the Time of the Last Quantifiable Concentration, Calculated by Trapezoidal Methods.(Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.)