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

Primary Purpose

Iliac Artery Stenosis

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Treatment of primary iliac artery stenosis and/or occlusive lesions
Sponsored by
Bentley InnoMed GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iliac Artery Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Hospital
  • Peking University First Hospital
  • Peking University People's Hospital
  • Peking University Third Hospital
  • Shanghai Ninth People's Hospital
  • The Second Affiliated Hospital of Soochow University
  • Suzhou Municipal Hospital
  • General Hospital of Tianjin Medical University
  • The Second Hospital of Tianjin Medical University
  • Tianjin First Center Hospital
  • The Central Hospital of Wuhan
  • The First Hospital of Zhejiang Province

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BeGraft Peripheral Stent Graft System

Bare metal stent system

Arm Description

Covered stent

bare metal stent

Outcomes

Primary Outcome Measures

Primary patency rate
The primary patency rate is defined as the absence of restenosis in the treated vessel segment without accompanying target lesion revascularisation (TLR) or amputation.

Secondary Outcome Measures

Device/Surgical success rate
Stent placement and integrity

Full Information

First Posted
July 15, 2019
Last Updated
June 19, 2023
Sponsor
Bentley InnoMed GmbH
Collaborators
Shanghai Micro Medical Devices Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04023370
Brief Title
Evaluation of the Efficacy and Safety of the Application of BeGraft Peripheral Stent Graft System
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bentley InnoMed GmbH
Collaborators
Shanghai Micro Medical Devices Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iliac Artery Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, multi-centre, randomised controlled trial design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BeGraft Peripheral Stent Graft System
Arm Type
Experimental
Arm Description
Covered stent
Arm Title
Bare metal stent system
Arm Type
Active Comparator
Arm Description
bare metal stent
Intervention Type
Device
Intervention Name(s)
Treatment of primary iliac artery stenosis and/or occlusive lesions
Intervention Description
Stent implantation
Primary Outcome Measure Information:
Title
Primary patency rate
Description
The primary patency rate is defined as the absence of restenosis in the treated vessel segment without accompanying target lesion revascularisation (TLR) or amputation.
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Device/Surgical success rate
Description
Stent placement and integrity
Time Frame
30 days, 6 months and 12 months following surgery, and then once a year from the 2nd to 5th year following surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Beijing Hospital
City
Beijing
Country
China
Facility Name
Peking University First Hospital
City
Peking
Country
China
Facility Name
Peking University People's Hospital
City
Peking
Country
China
Facility Name
Peking University Third Hospital
City
Peking
Country
China
Facility Name
Shanghai Ninth People's Hospital
City
Shanghai
Country
China
Facility Name
The Second Affiliated Hospital of Soochow University
City
Soochow
Country
China
Facility Name
Suzhou Municipal Hospital
City
Suzhou
Country
China
Facility Name
General Hospital of Tianjin Medical University
City
Tianjin
Country
China
Facility Name
The Second Hospital of Tianjin Medical University
City
Tianjin
Country
China
Facility Name
Tianjin First Center Hospital
City
Tianjin
Country
China
Facility Name
The Central Hospital of Wuhan
City
Wuhan
Country
China
Facility Name
The First Hospital of Zhejiang Province
City
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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