Femoropopliteal Artery Disease
Conditions
Interventions
Trail group:Drug-coated balloon
Control group:Standard balloon
Sponsors
Beijing Chaoyang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 85 years; 2. Ever underwent the bare-metal stenting angioplasty in the femoral-popliteal artery for the treatment of arteriosclerosis obliterans; 3. Intermittent claudication or critical limb ischemia 7 days to 2 years after stenting angioplasty, referred as Rutherford classification (category 2-5); 4. In-stent restenosis in the SFA and P1 segment of the popliteal artery (PA),more than 50% restenosis in the minimal luminal diameter within the stent-cover vessel, plus the 10-mm segments proximally and distally, compared to the mean diameter stent diameter measured by computed tomographic angiography (CTA); 5. Tibial run-off of at least 1 artery which however may be stenotic but amenable to PTA; 6. Treatment and follow-up should be voluntary and a informed consent form would be signed by the patient or legal guardian.
Exclusion criteria
Exclusion criteria: 1. Failure to cross the target lesion with a guidewire; 2. Severe flow-limiting dissections (=grade D) or residual stenosis >70% are generated after predilation; 3. Serious renal failure (serum creatinine >2.5 mg/dL); 4. Known intolerance allergy to aspirin, heparin, clopidogrel, paclitaxel, or contrast agent; 5. Planned amputation of the target limb; 6. Life expectancy <1 years; 7. Patients unable to give informed consent; 8. Patients enrolled in another drug or device study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| primary patency at 1 year follow-up; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success;Complication;Ankle-brachial index;Clinically-driven target lesion revascularization; | — |
Countries
China
Contacts
Public ContactChuan-jun Liao
Beijing Chaoyang Hospital, Capital Medical University
Outcome results
None listed