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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBrosMed Medical Co., Ltd

About this trial

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.

Eligibility criteria

Qualifiers

Aged 18 to 85 years, gender not restricted;

Rutherford grade 2 to 5

Diameter stenosis ≥70% by visual estimation or

Chronic total occlusion (CTO)

Disqualifiers

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.;

Trial design

Treatments tested in this trial

  • drug coating balloon angioplasty

Treatment groups

150 Participants
are divided into 1 treatment group

Sponsors and collaborators