peripheral arteria disease
Conditions
Interventions
Control group:Self-expanding stent graft
Experimental group:Ball expanded stent graft
Sponsors
Department of Vascular Surgery, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects are males or non-pregnant females >= 18 years of age, and their life expectancy is sufficient to complete all the research procedures. 2. Symptomatic peripheral arterial disease with moderate to severe claudication (Rutherford score 2-3 points) or with resting deficiency; bloody painful chronic limb ischemia CLI (Rutherford 4 points) or chronic CLI with ischemic ulcers ( Rutherford score 5-6 points). 3. The target lesion can be successfully passed through the guide wire and can be pre-expanded with a PTA balloon of appropriate size. 4. Diagnosis of patients with primary iliac artery disease (Trans-Atlantic Inter-Society Consensus, TASC II, TASC II A-D). 5. An informed consent form approved by the ethics committee must be provided.
Exclusion criteria
Exclusion criteria: 1. The subject had previously implanted a vascular graft in the intrinsic iliac blood vessel. 2. The subject has an abdominal aortic aneurysm (AAA) adjacent to the iliac artery target lesion, or the subject has a target iliac artery aneurysm or a target iliac artery perforation or dissection. 3. The subject's serum creatinine is >= 2.5 mg/dl or is on dialysis. 4. The subject is known to be allergic or sensitive to stainless steel (nickel), ePTFE or contrast agents. 5. Subjects are intolerant of antiplatelet, anticoagulant or thrombolytic drugs. 6. The subject has known uncorrectable bleeding factors or active coagulation dysfunction (platelet count <80,000/µL). 7. The subject had a stroke or transient ischemic attack (TIA) within 3 months before the operation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Revascularization (TLR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Device and/or Surgical Related Mortality ;All-cause Mortality;Amputation Rate;Acute Limb Ischemia Rate ;Incidence of Cardiovascular Events ;Target Vessel Reconstruction Rate;Phase I Patency Rate;Auxiliary Patency Rate;Phase II Patency Rate;Limp Distance;Creatinine;Ankle Brachial Index (ABI) at 1- , 6- , 12- , 24- and 36 months post-index procedure;Acute Procedure Success;Acute Lesion Success; | — |
Countries
China
Contacts
Public ContactYuan Ding
West China Hospital, Sichuan University
Outcome results
None listed