Status:
ACTIVE_NOT_RECRUITING
Evaluation of the Efficacy and Safety of the Application of BeGraft Peripheral Stent Graft System
Lead Sponsor:
Bentley InnoMed GmbH
Collaborating Sponsors:
Shanghai Micro Medical Devices Co., Ltd.
Conditions:
Iliac Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
This study adopts a prospective, multi-centre, randomised controlled trial design, aiming at evaluating the efficacy and safety of the BeGraft Peripheral Stent Graft System for primary iliac artery st...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT04023370
Start Date
September 19 2019
End Date
August 31 2025
Last Update
October 26 2024
Active Locations (12)
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1
Beijing Hospital
Beijing, China
2
Peking University First Hospital
Beijing, China
3
Peking University People's Hospital
Beijing, China
4
Peking University Third Hospital
Beijing, China