Arteriosclerosis obliterans of lower extremity
Conditions
Interventions
Experimental group:This experiment adopts the central randomization method based on computer system. When patients voluntarily sign informed consent and meet the screening criteria of the trial, resea
Control group:This experiment adopts the central randomization method based on computer system. After the patients voluntarily sign the informed consent and meet the screening criteria of the trial, t
Sponsors
Peking Union Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subject related: 1. Age 18 and above; 2. Life expectancy >=1 year; 3. The subject was diagnosed with lower extremity arteriosclerotic obliterans, intermittent claudication, or ischemic resting pain (Rutherford grades 2-4) and required revascularization of the iliac artery; 4. The subjects can understand the purpose of the experiment, voluntarily participate in and sign the informed consent examined and approved by the Ethics Committee; 5. Subject agrees to complete follow-up according to protocol requirements. Lesion related: 1. The subjects had single and/or multiple primary lesions in the iliac artery, with angiographic stenosis >=50% (including complete occlusion); 2. The reference diameter of the lesion vessel was 4.0-12.0mm, and the lesion length (unilateral) was less than 200mm; 3. The guide wire successfully passes through the lesion; 4. The inflow and outflow channels of the target lesions were unobstructed or had been successfully recanalized (the stenosis degree of upstream and downstream arteries on the same side of the angiographic lesions was <50%); 5. No more than 4 stents are planned to be implanted to treat target lesions.
Exclusion criteria
Exclusion criteria: Subject related: 1) Refusing to sign informed consent, or failing to follow up as required by the protocol; 2) Pregnant or lactating women, potentially fertile female subjects who were unable or unwilling to use effective contraception during the study period; 3) Participants who had undergone (or planned to undergo) coronary intervention within 30 days prior to enrollment; 4) Subjects who could not accurately evaluate the Rutherford scale of the limb where the target lesion was located; 5) Subjects with severe chronic renal insufficiency (serum creatinine >2.5mg/dL) and no dialysis treatment; 6) Subjects with uncorrected severe coagulation dysfunction (platelet count < 80*109/L) or uncontrolled active bleeding; Subjects with anticoagulation contraindications; 7) Subjects who cannot tolerate antiplatelet or anticoagulant therapy; 8) Subjects with bloodstream infections or other uncontrollable infections; 9) Nickel, titanium, expanded polytetrafluoroethylene (ePTFE), iodine contrast agents and other drugs used in the study Subjects who are allergic to substances; 10) Participants who have participated in other clinical trials or are currently participating in other clinical trials within 3 months before surgery; 11) The investigator considers that there are other circumstances in which clinical trials are not appropriate. Lesion related: 1) There is no normal artery segment at the proximal end of the target lesion for PSVR measurement by color Doppler ultrasound; 2) Single and/or multiple restenosis lesions in the subjects' iliac arteries; 3) Subjects who have received vascular surgery or interventional therapy in the same artery of the target lesion within 30 days and the non-target lesion cannot be treated before the target lesion; 4) The presence of other vascular stents or grafts in the vicinity of the target lesion (<=5mm); 5) The target lesion is scheduled to receive vascular bypass transplantation; 6) Proximal or distal target lesions combined with aneurysms affect stent placement; 7) The angiography before interventional surgery indicated perforation of the target vessel or the presence of vascular dissection; 8) The target lesion cannot be passed by the test instrument, or the target lesion needs to be pretreated by other treatment means other than conventional balloon angioplasty (such as plaque excision, cryogenic balloon angioplasty, cutting balloon, scoring balloon, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary patency;Phase I auxiliary patency rate;Secondary patency;Target lesion revascularization (TLR) rate;Target vessel revascularization (TVR) rate;Ankle-brachial index (ABI) compared with preoperative changes;The change of Rutherford grading compared with preoperative;Instrument success rate;Operation success rate; | — |
Countries
China
Contacts
Public ContactYuehong Zheng
Peking Union Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed