CompletedNot Applicable

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

South Korea119 participantsStarted 2019-03-24

Plain-language summary

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%).

Who can participate

Age range19 Years – 85 Years

SexALL

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Inclusion criteria

✓. ≥ 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;

Exclusion criteria

✕. 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;
✕. Those who need stenting due to vascular dissection that restricts blood flow of Grade D or higher after pre-dilation

What they're measuring

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

Timeframe: Follow-up CT angiography at 6 months after the procedure

Trial details

NCT IDNCT05134545

SponsorGenoss Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-30

View on ClinicalTrials.gov More Peripheral Artery Disease trials