Clinical trial NCT05134545: Compare the Effectiveness 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 Effectiveness and Safety of GENOSS® DCB Versus IN.PACT Admiral® DCB in Patients With Peripheral Artery Disease of Femoral and Popliteal Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
De Novo Stenosis
Lead sponsor: Genoss Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-26
Enrollment: 119
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: late lumen loss after procedure in patients with peripheral artery disease of femoral and popliteal artery
timeFrame: Follow-up CT angiography at 6 months after the procedure
Secondary outcomes:
measure: Target lesion revascularization
timeFrame: at 1 months, 6 months, and 12 months after procedure
measure: Change in ABI or TBI
timeFrame: at 1 month, 6 months, and 12 months after procedure
measure: Changes in Rutherford classification
timeFrame: at 1 month, 6 months, and 12 months after procedure
measure: Restenosis rate after procedure in patients with peripheral artery disease of femoral and popliteal artery
timeFrame: Follow-up CT angiography at 6 months after procedure
measure: Device success rate, %
timeFrame: immediately after the procedure
measure: Procedural success rate, %
timeFrame: at 12 months after procedure
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Department of Radiology, Ajou University School of Medicine
name: Je Hwan Won, MD
role: PRINCIPAL_INVESTIGATOR
References: