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

Not Applicable

Not yet recruiting

• Conditions: Femoropopliteal Artery Stenoses or Occlusive Lesions

• Registration Number: NCT07187128
• Lead Sponsor: BrosMed Medical Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study Start: 2025-09-22
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Primary Completion: 2028-10-10
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Patency Rate at 12 months post-procedure	12 months	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.

Secondary Outcome Measures

Name	Time	Method
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
MAEs Rates at 12 Months and 24 Months Post-Procedure	12, 24 months	MAEs: Include all-cause mortality within 30 days post-procedure, amputation of the treated limb, and clinically driven target vessel revascularization (TVR).

Trial Locations

Locations (2)

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chognqing, China