NCT05134545

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Genoss Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

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%).

Detailed description

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. Safety evaluation is confirmed through all adverse events, MAE (Major adverse event), vital signs, physical examination and laboratory test results that occur to the subject during the clinical trial period after procedure of the clinical trial medical device.

Conditions

• Peripheral Artery Disease
• De Novo Stenosis

Interventions

Type	Name	Description
DEVICE	Genoss® DCB	Peripheral Drug Coated Balloon
DEVICE	IN.PACT Admiral® DCB	Peripheral Drug Coated Balloon

Timeline

• Start date: 2019-03-24
• Primary completion: 2022-12-30
• Completion: 2023-06-30
• First posted: 2021-11-26
• Last updated: 2024-08-23

Locations

1 site across 1 country: South Korea