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

BrosMed Medical

Status: Not yet enrolling

Conditions: Femoropopliteal Artery Stenoses or Occlusive Lesions

Treatments: Device: drug coating balloon angioplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT07187128

BM-MK01

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

VaSecure Drug-Coated Peripheral Balloon Dilatation Catheter

Experimental group

Treatment:

Device: drug coating balloon angioplasty