In-stent restenosis of the femoral-popliteal artery
Conditions
Interventions
1:Drug-eluting Balloon. Percutaneous transluminal angioplasty.
2:Percutaneous transluminal angioplasty
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years old; both male and female are adimitted; 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 after stenting angioplasty, referred as Rutherford classification (category 2, 3, and 4); 4. 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. Single vessel runoff or better with at least 1 of 3 vessels (the anterior tibial artery, theposterior tibial artery and the peroneal artery) patent to the lower third of the calf; 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) Patients have a paclitaxel allergy or a iodine allergy; 2) Patients are younger than 18 years of age, or more than or equal to 80 years; 3) Patient with current medical condition with a life expectancy less than 3 months; 4) The patient had sympomatic myoinfarction within 3 months or uncontrollable heart failure; 5) The patient had severe respiratory failure (PO250 mmHg); 6) The patient had renal failure with creatine level more than 200 umol/L; 7) The patient had severe liver disfunction with alanine aminotransferase level over 3 times.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Luminal restenosis rate within the stent-cover vessel, plus the 10-mm segments proximally and distally by doppler ultrasound;peak systolic velocity ratio relative to the adjacent segment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ankle Brachial Index (ABI);Intimal thickness of lesion segment by doppler ultrasound;Pulse wave velocity(PWV); | — |
Contacts
Public ContactShen Chenyang
Peking University People's Hospital
Outcome results
None listed