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

NCT07187128 | Not Yet Recruiting

• 1 other identifier: BM-MK01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Primary Patency Rate at 12 months post-procedure

  12-month primary patency of the target lesion is defined as: absence of clinically driven target lesion revascularization and no Doppler ultrasound-diagnosed target lesion restenosis within 12 months postoperatively. Doppler ultrasound-diagnosed restenosis refers to a peak systolic velocity ratio (PSVR) ≥2.4 at the target lesion (indicating ≥50% luminal stenosis). Clinically Driven: Rutherford classification increase, ABI decrease, or imaging evidence of ≥70% stenosis. Target Lesion Revascularization: Includes any endovascular or open procedure at the target lesion site (e.g., PTA, stent placement, bypass surgery, thrombectomy, thrombolysis) or major amputation of the target limb.

  12 months

Secondary Outcomes (6)

• Device Success Rate

  Immediately after procedure

• Primary Patency Rate at 24 months post-procedure

  24 months

• Target Lesion Revascularization (TLR) Rate at 12 amd 24 months post-procedure

  12 months; 24 months

• Change in Rutherford classification from baseline at 6, 12, and 24 months postoperatively

  6, 12, 24 months

• Change in ABI (ankle-brachial index) from baseline at 12 and 24 months postoperatively

  12, 24 months

Study Arms (1)

VaSecure Drug-Coated Peripheral Balloon Dilatation Catheter

EXPERIMENTAL

Device: drug coating balloon angioplasty

Interventions

drug coating balloon angioplasty DEVICE

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

VaSecure Drug-Coated Peripheral Balloon Dilatation Catheter

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 85 years, gender not restricted;
• Rutherford grade 2 to 5
• 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)
• At least one native below-the-knee artery supplying the foot on the affected side preoperatively;
• The guidewire can successfully pass through the target lesion site within the vascular lumen;
• Agree to participate in this clinical study and voluntarily sign the informed consent form.

You may not qualify if:

• Absence of proximal inflow tract or persistent lack of proximal inflow after pretreatment
• Type D or higher dissection occurring after target lesion predilation;
• Residual diameter stenosis \>50% following target lesion predilation;
• Patients with known allergies to aspirin, clopidogrel, heparin, paclitaxel, contrast agents, etc.;
• Abnormal function of vital organs (liver/kidney/brain) deemed unsuitable for intervention by investigators;
• Documented allergy to aspirin, clopidogrel, heparin, paclitaxel/structural analogs, or contrast agents;
• Patients currently undergoing dialysis or immunosuppressive therapy;
• Presence of detectable thrombus in lower extremity arteries requiring intraoperative thrombolysis;
• History of stroke or ST-elevation myocardial infarction within 6 months prior to procedure;
• Pregnancy or lactation women;
• Currently participation in other drug/medical device clinical trials without completion;
• Patients deemed by the investigator to be unsuitable for participation in this study.

Sponsors & Collaborators

• BrosMed Medical Co., Ltd: lead

Study Sites (2)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chognqing, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): October 10, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

CN (2)