Femoropopliteal Artery Disease
Conditions
Interventions
1:DCB
2:PTA
Sponsors
Beijing Chaoyang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 85 years; 2. Rutherford classification (category 2-5); 3. De novo lesions (=70% diameter reduction or occlusion) more than 150 mm long in the SFA and P1 segment of the popliteal artery; 4. Reference vessel diameter of 4 to 8 mm; 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 enrolled in another drug or device study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| primary patency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinically-driven target lesion revascularization;Ankle-brachial index;Technical success;Complication; | — |
Countries
China
Contacts
Public ContactChuanjun Liao
Beijing Chaoyang Hospital, Capital Medical University
Outcome results
None listed