NCT01594684Unknown2 期
Cotavance™ Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Treatment of In-stent Restenosis in SFA and Popliteal Arteries COPA CABANA Study
Prof. Dr. med. Gunnar Tepe12 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 112
- 试验地点
- 12
- 主要终点
- Late Lumen Loss (LLL)
研究概览
简要总结
In stent restenosis in peripheral artery disease (superficial and popliteal artery) either treated with uncoated or paclitaxel coated balloons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •In-stent restenosis or re-occlusion at the target lesion due to an interventional treatment > 3 months prior to enrollment.
- •Has evidence of ≥ 70% stenosis or occlusion in the SFA and/or popliteal confirmed by angiography that is 3-27 cm long.
- •Reference vessel diameter of 3 to 7 mm (reference vessel diameter = normal vessel diameter 1 cm proximal of the index lesion)
- •Patients (men and women) with PAD disease category 2 to 5 according to Rutherford classification.
- •Patient is eligible for an operative vascular intervention in case of complications during the procedure.
- •Female patients of child bearing potential must have a negative pregnancy test 7 days at theprior to the time of intervention.
- •Fully informed and signed consent must be obtained from each patient.
- •Patients must be willing and able to continue study participation following study procedure in order to ensure completion of all procedures and observations required by protocol.
- •Patient has evidence of at least one run off vessel that does not also require treatment for significant (≥ 50% stenosis or occlusion) stenosis during the index procedure to the ankle/foot of the limb to be treated. Treatment of infrapopliteal lesions must be staged at least 30 days before or after the index procedure.
- •If restnosis occurs in both arms 30 days or later (re-re-sternosis)- treament with two drug eluting balloons at the same location (double dose)
排除标准
- •Patients with more than two lesions in the target vessel requiring treatment (if the distance between two lesions is less than 2 cm, the lesions should be counted as one lesion). The second lesion should also be treated with either coated or uncoated balloons (according to the randomization)
- •Guidewire cannot cross lesion and/or an intentional subintimal approach in the stented lesion is required.
- •Patients with stent fractures grade 2-
- •Inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to treatment of the study lesion.
- •Acute thrombosis of the study lesion requiring lysis or thrombectomy prior to the treatment of the study lesion.
- •Acutely occurring symptoms with a lyses or an operation as a therapeutic option within the last 6 weeks within the study limb.
- •Potential loss of leg due to critical or acute ischemia.
- •No patent distal run-off vessel.
- •Aneurysm in the blood vessel intended for intervention in this study.
- •Blood platelet count < 100.000/mm3 or >700.000/mm3, leukocyte count < 3.000/mm
- •Contra-indication to anticoagulation, or any anti-platelet agent (e.g. aspirin, heparin, clopidogrel, ticlopidine, abciximab), or paclitaxel.
- •Known intolerance or contra-indication (e.g. severe hepatic (with ALAT and/or ASAT > 3 times the normal reference range) or renal (creatinine > 1.1 mg/dl in women and >1.5 mg/dl in men) to contrast agents which cannot be adequately pre-treated, e.g. with adequate hydration.
- •Severe illnesses such as cancer, liver or renal diseases, myocardial insufficiency leading to protocol deviations and/or a reduced life expectancy of less than 2 years.
- •Manifest hyperthyreosis.
- •Latent hyperthyreosis without adequate therapy, e.g., previous blocking with Natriumperchlorat (Irenat®).
- •Significant gastrointestinal hemorrhage within the previous 6 months prior to study participation.
- •History of hemorrhagic diathesis or coagulopathy or rejection of blood transfusions.
- •Medical reason against double anti-platelet therapy in anti-coagulated patient, e.g., receiving coumadine.
- •Any severe medical condition that might interfere with the interpretation of the data or result in an unacceptable risk for the patient's participation in the study, according to the judgment of the clinical investigator.
- •Female patient who is pregnant or lactating.
- •Patient under 18 years of age.
- •Participation in another clinical study up to 30 days prior to study entry.
- •Previous participation in the same trialstudy (only one leg can be treated within the study).
结局指标
主要结局
Late Lumen Loss (LLL)
时间窗: 6 +/-2 months
• Late lumen loss (difference between the angiographic minimum lumen diameter (MLD) immediately and at 6 months post index procedure) evaluated by quantitative angiography. Analysis will be performed by an independent Angiographic Core Laboratory
次要结局
- • Procedural success(after intervention)
- Target lesion revascularization (TLR)(6, 12 and 24 months)
- Binary restenosis rate(6, 12 and 24 months)
- Target vessel revascularization (TVR)(6, 12 and 24 months)
- Rutherford category(6, 12 and 24 months)
- Ancle Brachial index (ABI)(6, 12 and 24 months)
- Late lumen loss (LLL)(24 months)
- Minimum lumen diameter (MLD)(12 and 24 months)
- Hospitalization(6, 12 and 24 months)
- safety(30days)
- resteosis pattern(6 and 24 months)
- Target lesion revascularization (TLR), clinical success and angiographic outcome (restenosis rate, late lumen loss) after second therapy(after intervention, 6, 12 and 24 months)
研究者
Prof. Dr. med. Gunnar Tepe
Head of the Deparment of Diagnostic and Interventional Radiology
Klinikum Rosenheim
研究点 (12)
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