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%).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
119
Peripheral Drug Coated Balloon
Peripheral Drug Coated Balloon
Ajou University Hospital
Suwon, South Korea
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
Time frame: Follow-up CT angiography at 6 months after the procedure
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Follow-up CT angiography at 6 months after procedure
Device success rate, %
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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.
Time frame: 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.
Time frame: at 12 months after procedure