A Multicenter, Prospective, Randomized, Double-blind, Pivotal Clinical Study to Evaluate the Effectiveness and Safety of GENOSS® DCB Versus IN.PACT Admiral® DCB in Patients With Peripheral Artery Disease of Femoral and Popliteal Artery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- late lumen loss after procedure in patients with peripheral artery disease of femoral and popliteal artery
研究概览
简要总结
The purpose of this clinical trial is to demonstrate the non-inferiority of GENOSS DCB versus IN.PACT Admiral DCB on late lumen loss 6 months after the procedure in patients with de novo or non-stented restenotic lesions of the superficial femoral artery and popliteal artery and to evaluate the safety.
This clinical trial will be conducted on a total of 118 patients at 11 domestic institutions (taking into account the dropout rate of 30%).
详细描述
In this clinical trial, IN.PACT Admiral, which is the most similar to GENOSS DCB, a test device, and the product type and purpose of use, and whose effectiveness has already been proven through numerous clinical studies, was selected as a control product.
Due to the nature of this clinical trial, the investigator cannot be blinded to the treatment method to which the subject is assigned, so it is designed as a double-blind design in which only the subject and the independent evaluator are blinded.
For efficacy and safety evaluation, follow-up is performed up to 12 months after procedure of the clinical trial medical device.
The primary endpoint of the effectiveness evaluation was performed by an independent evaluator and CT angiography at 6 months of in-segment late lumen loss.
It is evaluated the revascularization rate, Rutherford classification, the amount of change in ABI or TBI at 1, 6, and 12 months, the procedural success rate during the clinical trial period, and the device success rate immediately after the procedure.
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
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 19 years and ≤ 85 years of age
- •Documented ischemia with Rutherford classification 2, 3, 4 or 5
- •Target lesion is in the SFA and/or PPA
- •Reference vessel diameter ≥ 4 mm and ≤ 7 mm by visual estimate
- •Angiographic evidence that target lesion consists of a single de novo or non-stented restenotic lesion;
- •70% - 99% occluded with total lesion length ≥ 40 mm and ≤ 300 mm
- •100% occluded with total lesion length ≤ 100 mm
- •Combination lesions (a non-occlusive lesion that includes a totally occluded segment along its length) are eligible provided that (1) the combined lesion length is ≥ 40 mm and ≤ 300 mm and (2) the totally occluded segment is not greater than 100 mm in length.
- •Tandem or adjacent lesions are treated as a single lesion, the gap between the lesions is ≤ 30 mm, and the total combined lesion length including the distance between the lesions is ≥ 40 mm and ≤ 300 mm
排除标准
- •Stroke or STEMI within 3 months prior to enrollment
- •Acute thrombosis or acute aneurysm in the target lesion
- •History of or planning to have a major amputation in the leg
- •Failure to successfully cross the target lesion with a guidewire
- •Poor distal run-off artery to the ankle or lower
- •Known allergies or sensitivities to paclitaxel, shellac, vitamin E, heparin, aspirin, other anticoagulant/antiplatelet therapies or contrast agent
- •Target lesion is one of the following;
- •In-stent restenosis (ISR)
- •Restenosis after DCB procedure
- •Previously treated with bypass surgery
- •Severe concentric calcified lesions on angiography where pre-dilation cannot be performed or failed, and the procedure for the device for clinical trials is inadequate
- •Those who need stenting due to vascular dissection that restricts blood flow of Grade D or higher after pre-dilation
- •Any major (e.g., cardiac, peripheral, abdominal) intervention (including in the contralateral SFA/PPA) planned within 30 days post index procedure
- •Life expectancy, in the Investigator's opinion, is less than 12 months
- •Chronic renal insufficiency with serum creatinine > 2.5 mg/dL
结局指标
主要结局
late lumen loss after procedure in patients with peripheral artery disease of femoral and popliteal artery
时间窗: Follow-up CT angiography at 6 months after the procedure
late lumen loss between test group and control group evaluated by CT angiography in patients with peripheral artery disease of femoral and popliteal artery
次要结局
- Change in ABI or TBI(at 1 month, 6 months, and 12 months after procedure)
- Changes in Rutherford classification(at 1 month, 6 months, and 12 months after procedure)
- Device success rate, %(immediately after the procedure)
- Procedural success rate, %(at 12 months after procedure)
- Target lesion revascularization(at 1 months, 6 months, and 12 months after procedure)
- Restenosis rate after procedure in patients with peripheral artery disease of femoral and popliteal artery(Follow-up CT angiography at 6 months after procedure)