NCT01412541已完成不适用
A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries
C. R. Bard104 个研究点 分布在 4 个国家目标入组 532 人开始时间: 2011年7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
- 532
- 试验地点
- 104
- 主要终点
- Percentage of Participants With Primary Patency of the Target Lesion at 12 Months Post Index Procedure
研究概览
简要总结
The purpose of the study is to demonstrate the superior efficacy and non-inferior safety of the Moxy Drug Coated Balloon by direct comparison to standard percutaneous transluminal angioplasty (PTA) catheter for treatment of stenosis of the femoropopliteal arteries.
详细描述
The Moxy Drug Coated Balloon is indicated for percutaneous transluminal angioplasty of obstructive de novo or non-stented restenotic lesions in native femoropopliteal arteries up to 15 cm in length and ≥4.0 to ≤6.0 mm in diameter. This study will randomize approximately 476 patients who will receive either the Moxy balloon or standard balloon angioplasty at 55 global investigational sites. Subjects will be blinded to treatment until 12 months and will participate in long term follow-up for 5 years.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All Duplex Ultrasound operators, core lab evaluators, and members of the Clinical Events Committee (CEC) will be blinded to the subject's treatment assignment. Both the subject as well as the Investigator conducting the follow-up visit will be blinded to treatment until the completion of the 12 month visit.
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
- •Clinical Inclusion Criteria:
- •Male or non-pregnant female ≥18 years of age;
- •Rutherford Clinical Category 2-4;
- •Patient is willing to provide informed consent, is geographically stable and comply with the required follow up visits, testing schedule and medication regimen;
- •Angiographic Lesion Inclusion Criteria:
- •Length ≤15 cm;
- •Up to two focal lesions or segments within the designated 15 cm length of vessel may be treated (e.g. two discrete segments, separated by several cm, but both falling within a composite length of ≤15 cm);
- •≥70% stenosis by visual estimate;
- •Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk;
- •de novo lesion(s) or non-stented restenotic lesion(s) >90 days from prior angioplasty procedure;
- •Lesion is located at least 3 cm from any stent, if target vessel was previously stented;
- •Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix;
- •Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion;
- •A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow artery lesions); NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication.
- •At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been revascularized (treatment of outflow disease is NOT permitted during the index procedure);
- •Contralateral limb lesion(s) cannot be treated within 2 weeks before and/or planned 30 days after the protocol treatment in order to avoid confounding complications;
- •No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment.
排除标准
- •Patients will be excluded if ANY of the following conditions apply:
- •Pregnant or planning on becoming pregnant or men intending to father children;
- •Life expectancy of <5 years;
- •Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in another clinical trial during the follow up period is not allowed.
- •History of hemorrhagic stroke within 3 months;
- •Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;
- •History of myocardial infarction (MI), thrombolysis or angina within 2 weeks of enrollment;
- •Rutherford Class 0, 1, 5 or 6;
- •Renal failure or chronic kidney disease with modification in diet in renal disease glomerular filtration rate (MDRD GFR) ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis);
- •Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;
- •Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication;
- •Anticipated use of IIb/IIIa inhibitor prior to randomization;
- •Ipsilateral retrograde access;
- •Composite lesion length is >15 cm or there is no normal proximal arterial segment in which duplex flow velocity can be measured;
- •Significant inflow disease. Successful treatment of inflow disease allowed prior to target lesion treatment;
- •Known inadequate distal outflow (>50 % stenosis of distal popliteal and/or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion;
- •Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel;
- •Severe calcification that renders the lesion un-dilatable;
- •Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.).
结局指标
主要结局
Percentage of Participants With Primary Patency of the Target Lesion at 12 Months Post Index Procedure
时间窗: 12 months post index procedure
Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio (PSVR) ≥2.5) and freedom from target lesion revascularization (TLR).
Percentage of Participants With Composite Freedom From All-Cause Peri-Operative (≤30 Day) Death and Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 12 Months Post Index Procedure
时间窗: 12 months post index procedure
Composite of freedom from all-cause peri-operative (≤30 day) death and freedom at 1 year from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death.
次要结局
- Change in Six Minute Walk Test Distance at 6, 12, and 24 Months Compared to Baseline(6, 12, and 24 months from baseline)
- Change in Score on the Short Form Quality of Life Measure (Physical Component) at 6, 12, and 24 Months Compared to Baseline.(6, 12, and 24 months)
- Change in Quality of Life (Mental Component) on the Short-form 36 (SF-36 v2) at 6, 12, and 24 Months Compared to Baseline(6, 12, and 24 months from baseline)
- Number of Acute Device Success at Time of Index Procedure(At time of Index Procedure)
- Number of Participants With Technical and Procedural Success(At time of Index Procedure)
- Number of Participants With Duplex Ultrasound (DUS) Clinical Patency at 6, 12, and 24 Months Post Index Procedure(6, 12, and 24 months post index porcedure)
- Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline(6, 12, and 24 months post index procedure)
- Number of Participants With Primary Patency at 6, 12, and 24 Months Post Index Procedure(6, 12, and 24 months post index procedure)
- Number of Participants With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6, 12, and 24 Months Post Index Procedure(6, 12, and 24 months post index procedure)
- Change in Walking Impairment Questionnaire (WIQ) Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline.(6, 12, and 24 months post index procedure)
- Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure(6, 12, and 24 months post index procedure)
- Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline(6, 12, and 24 months from baseline)
- Number of Participants With All Cause Death, Amputation, Target Vessel Revascularization, Reintervention for Thrombosis, Major and Minor Vascular Complications, and Readmission for Cardiovascular Events at 1, 6, 12, 24, 36, 48, and 60 Months PPI.(1, 6, 12, 24, 36, 48, and 60 months post index procedure)
- Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 6, 12, and 24 Months Compared to Baseline.(6, 12, and 24 months)
- Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Porcedure(30 days post index procedure)
- Number of Participants With Composite of Freedom From All-Cause Perioperative (<30 Day) Death and Freedom From the Following at 1,6, 24, 36, 48, and 60 Months: Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death(1, 6, 24, 36, 48, and 60 months post index procedure)
研究者
研究点 (104)
Loading locations...
相似试验
已完成
3 期
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)Diabetes Mellitus, Type 2NCT00094757Merck Sharp & Dohme LLC521
已完成
3 期
Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal InfectionIntraabdominal InfectionsNCT01069900Bayer458
已完成
3 期
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative ColitisUlcerative ColitisNCT02065557AbbVie101
已完成
4 期
A Prospective Randomized Trial on Mycophenolate Mofetil in Risk Penetrating KeratoplastyCorneal TransplantationNCT00411515University Hospital Freiburg
已完成
3 期
Phase III Study of CG100649 in Osteoarthritis PatientsLocalized Primary Osteoarthritis of HipLocalized Primary Osteoarthritis of KneeNCT01765296CrystalGenomics, Inc.362