A Post-Market Study of Drug-Coated Peripheral Balloon Dilatation Catheter in Treating Femoropopliteal Artery Stenosis or Occlusive Lesions.

NCT ID: NCT07187128

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-22
• Study Completion Date: 2028-12-30

Brief Summary

T he Purpose of the Study is to evaluation of the Long-Term Safety and Effectiveness of a Drug-Coated Peripheral Balloon Dilatation Catheter in the Treatment of Femoropopliteal Artery Stenoses or Occlusive Lesions.

Conditions

Femoropopliteal Artery Stenoses or Occlusive Lesions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VaSecure Drug-Coated Peripheral Balloon Dilatation Catheter

Group Type: EXPERIMENTAL

drug coating balloon angioplasty

Intervention Type: DEVICE

The subjects underwent drug coating balloon angioplasty to treat femoropopliteal artery stenosis or occlusive lesions

Interventions

drug coating balloon angioplasty

The subjects underwent drug coating balloon angioplasty to treat femoropopliteal artery stenosis or occlusive lesions

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Aged 18 to 85 years, gender not restricted;

2. Rutherford grade 2 to 5

3. Target lesions located in the superficial femoral artery (SFA) and/or proximal popliteal artery requiring percutaneous transluminal angioplasty (PTA), with the following characteristics:

• Diameter stenosis ≥70% by visual estimation or
• Chronic total occlusion (CTO)

4. At least one native below-the-knee artery supplying the foot on the affected side preoperatively;

5. The guidewire can successfully pass through the target lesion site within the vascular lumen;

6. Agree to participate in this clinical study and voluntarily sign the informed consent form.

Exclusion Criteria

1. Absence of proximal inflow tract or persistent lack of proximal inflow after pretreatment

2. Type D or higher dissection occurring after target lesion predilation;

3. Residual diameter stenosis >50% following target lesion predilation;

4. Patients with known allergies to aspirin, clopidogrel, heparin, paclitaxel, contrast agents, etc.;

5. Abnormal function of vital organs (liver/kidney/brain) deemed unsuitable for intervention by investigators;

6. Documented allergy to aspirin, clopidogrel, heparin, paclitaxel/structural analogs, or contrast agents;

7. Patients currently undergoing dialysis or immunosuppressive therapy;

8. Presence of detectable thrombus in lower extremity arteries requiring intraoperative thrombolysis;

9. History of stroke or ST-elevation myocardial infarction within 6 months prior to procedure;

10. Pregnancy or lactation women;

11. Currently participation in other drug/medical device clinical trials without completion;

12. Patients deemed by the investigator to be unsuitable for participation in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BrosMed Medical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chognqing, China

Countries

China

Facility Contacts

Lianrui Guo

Role: primary

Guolianrui@xwhosp.org

010-83199270

Fenghe Li

Role: primary

Lifenghe@163.com

023-89011876

Other Identifiers

BM-MK01

Identifier Type: -

Identifier Source: org_study_id