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

Primary Purpose

Peripheral Artery Disease, De Novo Stenosis

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Genoss® DCB

IN.PACT Admiral® DCB

About this trial

This is an interventional treatment trial for Peripheral Artery Disease

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

≥ 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;
- 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:

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

Sites / Locations

Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Genoss® DCB

IN.PACT Admiral® DCB

Arm Description

Paclitaxel Coated PTA Balloon Catheter

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT05134545

First Posted

November 2, 2021

Last Updated

September 11, 2023

Sponsor

Genoss Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05134545

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

March 24, 2019 (Actual)

Primary Completion Date

December 30, 2022 (Actual)

Study Completion Date

June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genoss Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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 efficacy 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 efficay 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Artery Disease, De Novo Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

119 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Genoss® DCB

Arm Type

Experimental

Arm Description

Paclitaxel Coated PTA Balloon Catheter

Arm Title

IN.PACT Admiral® DCB

Arm Type

Active Comparator

Arm Description

Paclitaxel Coated PTA Balloon Catheter

Intervention Type

Device

Intervention Name(s)

Genoss® DCB

Intervention Description

Peripheral Drug Coated Balloon

Intervention Type

Device

Intervention Name(s)

IN.PACT Admiral® DCB

Intervention Description

Peripheral Drug Coated Balloon

Primary Outcome Measure Information:

Title

late lumen loss after procedure in patients with peripheral artery disease of femoral and popliteal artery

Description

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

Secondary Outcome Measure Information:

Title

Target lesion revascularization

Description

Time Frame

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

Title

Change in ABI or TBI

Description

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

Title

Changes in Rutherford classification

Description

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

Title

Restenosis rate after procedure in patients with peripheral artery disease of femoral and popliteal artery

Description

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

Title

Device success rate, %

Description

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

Title

Procedural success rate, %

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ≥ 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; 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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Je Hwan Won, MD

Organizational Affiliation

Department of Radiology, Ajou University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ajou University Hospital

City

Suwon

ZIP/Postal Code

16499

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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