NCT04023370

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

Evaluation of the Efficacy and Safety of the Application of BeGraft Peripheral Stent Graft System in Interventional Treatment of Revascularisation for Primary Iliac Artery Stenosis and/or Occlusive Lesions: a Prospective, Multi-centre, Randomised Controlled Clinical Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: Bentley InnoMed GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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 stenosis and/or occlusive lesions. A total of 182 subjects are planned to be enrolled, with all consecutively enrolled subjects being randomly assigned to an experimental group (BeGraft group, n=91) and a control group (bare metal stent group, n=91) in the ratio of 1:1 and respectively treated using the BeGraft Peripheral Stent Graft System and the bare metal stent system. Follow-up visits are carried out for the above-mentioned 182 subjects at baseline, upon discharge from hospital, at 30 days, 6 months, 12 months and then once a year from the 2nd to 5th year following surgery. A Doppler ultrasound (DUS) examination is carried out when subjects return to hospital at 6 months following surgery, and a CT angiography (CTA) examination when returning 12 months following surgery, with telephone follow-ups being conducted at 30 days and then once a year from the 2nd to 5th year following surgery.

Conditions

• Iliac Artery Stenosis

Interventions

Type	Name	Description
DEVICE	Treatment of primary iliac artery stenosis and/or occlusive lesions	Stent implantation

Timeline

• Start date: 2019-09-19
• Primary completion: 2022-09-30
• Completion: 2025-08-31
• First posted: 2019-07-17
• Last updated: 2024-10-26

Locations

12 sites across 1 country: China