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
Abstract
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%).
Conditions: Peripheral Artery Disease, De Novo Stenosis.
Primary outcome: late lumen loss after procedure in patients with peripheral artery disease of femoral and popliteal artery.
Enrollment: 119 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 119 participants or records.
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