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

Not Applicable

Completed

• Conditions: Peripheral Artery Disease; De Novo Stenosis
• Interventions: Device: IN.PACT Admiral® DCB; Device: Genoss® DCB

• Registration Number: NCT05134545
• Lead Sponsor: Genoss Co., Ltd.

Brief 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.

Study Timeline

• Study Start: 2019-03-24
• Study First Submitted: 2021-11-02
• Study First Submitted QC: 2021-11-14
• Study First Posted: 2021-11-26
• Primary Completion: 2022-12-30
• Study Completion: 2023-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IN.PACT Admiral® DCB	IN.PACT Admiral® DCB	Paclitaxel Coated PTA Balloon Catheter
Genoss® DCB	Genoss® DCB	Paclitaxel Coated PTA Balloon Catheter

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in ABI or TBI	at 1 month, 6 months, and 12 months after procedure	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.
Changes in Rutherford classification	at 1 month, 6 months, and 12 months after procedure	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.
Device success rate, %	immediately after the procedure	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.
Procedural success rate, %	at 12 months after procedure	During the clinical trial period, no postoperative death, target vessel revascularization (TVR), lower extremity amputation, or target lesion thrombosis is defined as procedural success.
Target lesion revascularization	at 1 months, 6 months, and 12 months after procedure	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
Restenosis rate after procedure in patients with peripheral artery disease of femoral and popliteal artery	Follow-up CT angiography at 6 months after procedure	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.

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of