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Clinical Trials in China / NCT04023370
Active, not recruiting Not applicable

Evaluation of the Efficacy and Safety of the Application of BeGraft Peripheral Stent Graft System

NCT04023370 · tracked via the Priya Life Science China tracker
Sponsor
Bentley InnoMed GmbH
Phase
Not applicable
Started
2019-09-19
Last updated
2024-10-26

Condition(s) studied

Iliac Artery Stenosis

Investigational drug(s) / intervention(s)

Treatment of primary iliac artery stenosis and/or occlusive lesions

Treatment of primary iliac artery stenosis and/or occlusive lesions: Stent implantation

Study 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 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)

Trial sites (12)

FacilityCityRegionStatus
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 Suzhou China
General Hospital of Tianjin Medical University Tianjin China
The Second Hospital of Tianjin Medical University Tianjin China
Tianjin First Center Hospital Tianjin China
The Central Hospital of Wuhan Wuhan China
The First Hospital of Zhejiang Province Zhejiang China

Other trials for the same condition

Official registry record

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.

View NCT04023370 on ClinicalTrials.gov ↗ ← All trials in China