The trial will be conducted to evaluate the safety and efficacy of the BeGraft Peripheral Stent Graft System in interventional revascularisation for subjects with primary iliac artery stenosis and/or occlusive lesions by conducting a multi-centre, randomised controlled clinical study with a bare metal stent system as the control, thus providing a basis for the formal use of the product in China
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Aged ≥18 years old, no restrictions in terms of male or female;
* Participating in the trial voluntarily, and having signed the informed consent form;
* TASC class A, B, C or D lesions of the common iliac artery and/or external iliac artery;
* Primary iliac atherosclerotic stenosis and/or occlusive lesions;
* Total length of lesions on the affected side ≤100 mm.
Exclusion Criteria:
* Expected survival period \<12 months;
* Pregnant women or those unable to take effective contraceptive measures during the trial;
* Aneurysms present close to the target lesion;
* Acute or subacute thrombosis within the target vessel;
* Previously unobstructed internal iliac artery being blocked (diameter stenosis \<70%) by the stented region;
* Total occlusive lesions, with the guidewire being unable to return the true lumen in the iliac artery;
* Severe calcification at the target lesion, with the catheter being unable to pass;
* Allergic to cobalt-chromium alloy (L605), ePFTE coating material, carbon coating, contrast agent, antiplatelet agents, anticoagulant drugs or presenting with contraindications;
* Total occlusion of the superficial femoral artery and deep femoral artery, with there being no outflow tract;
* Suffering from extensive diffuse disease at the distal end, resulting in poor blood flow in the outflow tract following stent placement;
* A history of coagulation disorders;
* The subject's mental state making it impossible for them to comprehend the nature, extent and possible consequences of the trial, or having a language barrier making it difficult for the subject to give their informed consent;
* Poor cooperation or potentially poor compliance with the protocol which may cause deviations during the trial.
Primary outcome measure(s)
Primary patency rate — 12 month The primary patency rate is defined as the absence of restenosis in the treated vessel segment without accompanying target lesion revascularisation (TLR) or amputation.
Trial sites (12)
Facility
City
Region
Status
Beijing Hospital
Beijing
China
Peking University First Hospital
Beijing
China
Peking University People's Hospital
Beijing
China
Peking University Third Hospital
Beijing
China
Shanghai Ninth People's Hospital
Shanghai
China
Suzhou Municipal Hospital
Suzhou
China
The Second Affiliated Hospital of Soochow University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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