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

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%).

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease; De Novo Stenosis
• Intervention / Treatment: Device: Genoss® DCB; Device: IN.PACT Admiral® DCB

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 Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of, 16499
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Genoss® DCB; Paclitaxel Coated PTA Balloon Catheter	Device: Genoss® DCB; Peripheral Drug Coated Balloon
Active Comparator: IN.PACT Admiral® DCB; Paclitaxel Coated PTA Balloon Catheter	Device: IN.PACT Admiral® DCB; Peripheral Drug Coated Balloon

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Genoss Co., Ltd.
• Investigators: Principal Investigator: Je Hwan Won, MD, Department of Radiology, Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2019
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: November 2, 2021
• First Submitted That Met QC Criteria: November 14, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: CSP-DS1411

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No