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

NCT05134545 | Completed

• 1 other identifier: CSP-DS1411
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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%).

Conditions

Peripheral Artery Disease; De Novo Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Target lesion revascularization

  at 1 months, 6 months, and 12 months after procedure

• Change in ABI or TBI

  at 1 month, 6 months, and 12 months after procedure

• Changes in Rutherford classification

  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

  Follow-up CT angiography at 6 months after procedure

• Device success rate, %

  immediately after the procedure

Study Arms (2)

Genoss® DCB

EXPERIMENTAL

Paclitaxel Coated PTA Balloon Catheter

Device: Genoss® DCB

IN.PACT Admiral® DCB

ACTIVE COMPARATOR

Paclitaxel Coated PTA Balloon Catheter

Device: IN.PACT Admiral® DCB

Interventions

Genoss® DCB DEVICE

Peripheral Drug Coated Balloon

Genoss® DCB

IN.PACT Admiral® DCB DEVICE

Peripheral Drug Coated Balloon

IN.PACT Admiral® DCB

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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;
• % - 99% occluded with total lesion length ≥ 40 mm and ≤ 300 mm
• % 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genoss Co., Ltd.: lead

Study Sites (1)

Ajou University Hospital

Suwon, 16499, South Korea

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Je Hwan Won, MD

  Department of Radiology, Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 26, 2021
• Study Start: March 24, 2019
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

KR (1)