Peripheral Artery Disease Clinical Trial
Official title:
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
NCT number | NCT05134545 |
Other study ID # | CSP-DS1411 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 24, 2019 |
Est. completion date | June 30, 2023 |
Verified date | February 2023 |
Source | Genoss Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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%).
Status | Completed |
Enrollment | 119 |
Est. completion date | June 30, 2023 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. = 19 years and = 85 years of age 2. Documented ischemia with Rutherford classification 2, 3, 4 or 5 3. Target lesion is in the SFA and/or PPA 4. Reference vessel diameter = 4 mm and = 7 mm by visual estimate 5. 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: 1. Stroke or STEMI within 3 months prior to enrollment 2. Acute thrombosis or acute aneurysm in the target lesion 3. History of or planning to have a major amputation in the leg 4. Failure to successfully cross the target lesion with a guidewire 5. Poor distal run-off artery to the ankle or lower 6. Known allergies or sensitivities to paclitaxel, shellac, vitamin E, heparin, aspirin, other anticoagulant/antiplatelet therapies or contrast agent 7. 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 8. Those who need stenting due to vascular dissection that restricts blood flow of Grade D or higher after pre-dilation 9. Any major (e.g., cardiac, peripheral, abdominal) intervention (including in the contralateral SFA/PPA) planned within 30 days post index procedure 10. Life expectancy, in the Investigator's opinion, is less than 12 months 11. Chronic renal insufficiency with serum creatinine > 2.5 mg/dL |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Ajou University Hospital | Suwon |
Lead Sponsor | Collaborator |
---|---|
Genoss Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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