peripheral artery disease
Conditions
Interventions
Randomized Control Arm with concomitant below the knee artery interventions
Randomized Control Arm without concomitant below the knee artery interventions
Sponsors
Sakakibara Heart Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)patients required endovacular treatment for femoro-popliteal artery complicated with all ipsilateral below-the-knee artery feeding under anckle narrowed more than 90% 2)patients with agreement for this study
Exclusion criteria
Exclusion criteria: 1)Life expectancy within 6months 2)allergy of contrast agents 3)under 20 years old 4)inappropiriate patients determined from study director 5)patients unavailable of antiplatelet agents and anticoagulant 6)Critical limb ischemia patients that revascularization to below-the-knee artery is scheduled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restenosis rate of the target femoro-popliteal artery by duplex scan at one year | — |
Secondary
| Measure | Time frame |
|---|---|
| death, myocardial infarction, bleeding lower limb event(revascularization, acute limb ischemia), lower limb amptation, lower limb sympton(WIQ score) | — |
Countries
Japan
Contacts
Public ContactClinical Trials Support Office
Sakakibara Heart Institute Clinical Trials Support Office
Outcome results
None listed