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Not yet recruiting NCT07187128

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

No phase Interventional Femoropopliteal Artery Stenoses or Occlusive Lesions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: drug coating balloon angioplasty.
Who it may be relevant to
Registry conditions: Femoropopliteal Artery Stenoses or Occlusive Lesions. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

  • Primary Patency Rate at 12 months post-procedure [Time frame: 12 months]
Secondary outcome measures (6)
  • Device Success Rate [Time frame: Immediately after procedure]
  • Primary Patency Rate at 24 months post-procedure [Time frame: 24 months]
  • Target Lesion Revascularization (TLR) Rate at 12 amd 24 months post-procedure [Time frame: 12 months; 24 months]
  • Change in Rutherford classification from baseline at 6, 12, and 24 months postoperatively [Time frame: 6, 12, 24 months]
  • Change in ABI (ankle-brachial index) from baseline at 12 and 24 months postoperatively [Time frame: 12, 24 months]
  • MAEs Rates at 12 Months and 24 Months Post-Procedure [Time frame: 12, 24 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Xuanwu Hospital Capital Medical University — Beijing
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing

Identifiers

NCT: NCT07187128 · BM-MK01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗