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

Study Overview
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Brief Summary
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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
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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 efficacy 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 efficay 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.

Official Title
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A Multicenter, Prospective, Randomized, Double-blind, Pivotal Clinical Study to Evaluate the Efficacy and Safety of GENOSS® DCB Versus IN.PACT Admiral® DCB in Patients With Peripheral Artery Disease of Femoral and Popliteal Artery

Conditions
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De Novo Stenosis, Peripheral Artery Disease

Intervention / Treatment
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* Device: Genoss® DCB
* Device: IN.PACT Admiral® DCB


Participation Criteria
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Eligibility Criteria
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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; 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 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; 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genoss® DCB<br>Paclitaxel Coated PTA Balloon Catheter | Device: Genoss® DCB<br>* Peripheral Drug Coated Balloon<br>|
| Active Comparator: IN.PACT Admiral® DCB<br>Paclitaxel Coated PTA Balloon Catheter | Device: IN.PACT Admiral® DCB<br>* Peripheral Drug Coated Balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| late lumen loss after procedure in patients with peripheral artery disease of femoral and popliteal artery | late lumen loss between test group and control group evaluated by CT angiography in patients with peripheral artery disease of femoral and popliteal artery | Follow-up CT angiography at 6 months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion revascularization | Proportion of subjects who underwent revascularization because the ABI (or TBI) decreased by 20% or more, or exceeded 0.15, or showed clinically significant ischemic symptoms compared to immediately after the procedure | at 1 months, 6 months, and 12 months after procedure | 
| Change in ABI or TBI | The amount of ABI(Ankle-brachial index) or TBI(Toe-brachial index) change after the procedure compared to before the procedure is evaluated between the test group and the control group. | at 1 month, 6 months, and 12 months after procedure | 
| Changes in Rutherford classification | The amount of change in Rutherford classification after the procedure compared to before the procedure is evaluated between the test group and the control group. | at 1 month, 6 months, and 12 months after procedure | 
| Restenosis rate after procedure in patients with peripheral artery disease of femoral and popliteal artery | Restenosis is defined as a case where the DS(Diameter stenosis) of the reference vessel diameter is 50% or more when the successfully treated lesion is evaluated through CT angiography. | Follow-up CT angiography at 6 months after procedure | 
| Device success rate, % | It is defined as a device that has successfully reached the target lesion during the procedure, undergoes normal balloon inflation and deflation, and is fully recovered without balloon rupture. | immediately after the procedure | 
| Procedural success rate, % | During the clinical trial period, no postoperative death, target vessel revascularization (TVR), lower extremity amputation, or target lesion thrombosis is defined as procedural success. | at 12 months after procedure |