Compare the Effectiveness and Safety of Genoss® DCB and IN.PACT Admiral® DCB in Patients With Peripheral Artery Disease

Not Applicable

Completed

• Conditions: Peripheral Artery Disease; De Novo Stenosis

• Registration Number: NCT05134545
• Lead Sponsor: Genoss Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-2
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

Inclusion Criteria:<br><br> 1. = 19 years and = 85 years of age<br><br> 2. Documented ischemia with Rutherford classification 2, 3, 4 or 5<br><br> 3. Target lesion is in the SFA and/or PPA<br><br> 4. Reference vessel diameter = 4 mm and = 7 mm by visual estimate<br><br> 5. Angiographic evidence that target lesion consists of a single de novo or non-stented<br> restenotic lesion;<br><br> - 70% - 99% occluded with total lesion length = 40 mm and = 300 mm<br><br> - 100% occluded with total lesion length = 100 mm<br><br> - Combination lesions (a non-occlusive lesion that includes a totally occluded<br> segment along its length) are eligible provided that (1) the combined lesion<br> length is = 40 mm and = 300 mm and (2) the totally occluded segment is not<br> greater than 100 mm in length.<br><br> - Tandem or adjacent lesions are treated as a single lesion, the gap between the<br> lesions is = 30 mm, and the total combined lesion length including the distance<br> between the lesions is = 40 mm and = 300 mm<br><br>Exclusion Criteria:<br><br> 1. Stroke or STEMI within 3 months prior to enrollment<br><br> 2. Acute thrombosis or acute aneurysm in the target lesion<br><br> 3. History of or planning to have a major amputation in the leg<br><br> 4. Failure to successfully cross the target lesion with a guidewire<br><br> 5. Poor distal run-off artery to the ankle or lower<br><br> 6. Known allergies or sensitivities to paclitaxel, shellac, vitamin E, heparin,<br> aspirin, other anticoagulant/antiplatelet therapies or contrast agent<br><br> 7. Target lesion is one of the following;<br><br> - In-stent restenosis (ISR)<br><br> - Restenosis after DCB procedure<br><br> - Previously treated with bypass surgery<br><br> - Severe concentric calcified lesions on angiography where pre-dilation cannot be<br> performed or failed, and the procedure for the device for clinical trials is<br> inadequate<br><br> 8. Those who need stenting due to vascular dissection that restricts blood flow of<br> Grade D or higher after pre-dilation<br><br> 9. Any major (e.g., cardiac, peripheral, abdominal) intervention (including in the<br> contralateral SFA/PPA) planned within 30 days post index procedure<br><br> 10. Life expectancy, in the Investigator's opinion, is less than 12 months<br><br> 11. Chronic renal insufficiency with serum creatinine > 2.5 mg/dL

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
late lumen loss after procedure in patients with peripheral artery disease of femoral and popliteal artery

Secondary Outcome Measures

Name	Time	Method
Target lesion revascularization;Change in ABI or TBI;Changes in Rutherford classification;Restenosis rate after procedure in patients with peripheral artery disease of femoral and popliteal artery;Device success rate, %;Procedural success rate, %