NCT04023370

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 19, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

3 years

First QC Date

July 15, 2019

Last Update Submit

October 24, 2024

Conditions

Iliac Artery Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 month

Secondary Outcomes (1)

  • Device/Surgical success rate

    30 days, 6 months and 12 months following surgery, and then once a year from the 2nd to 5th year following surgery

Study Arms (2)

BeGraft Peripheral Stent Graft System

EXPERIMENTAL

Covered stent

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

Bare metal stent system

ACTIVE COMPARATOR

bare metal stent

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

Interventions

Treatment of primary iliac artery stenosis and/or occlusive lesionsDEVICE

Stent implantation

Bare metal stent systemBeGraft Peripheral Stent Graft System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Beijing Hospital

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

Peking University People's Hospital

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

Shanghai Ninth People's Hospital

Shanghai, China

Location

Suzhou Municipal Hospital

Suzhou, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, China

Location

General Hospital of Tianjin Medical University

Tianjin, China

Location

The Second Hospital of Tianjin Medical University

Tianjin, China

Location

Tianjin First Center Hospital

Tianjin, China

Location

The Central Hospital of Wuhan

Wuhan, China

Location

The First Hospital of Zhejiang Province

Zhejiang, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, multi-centre, randomised controlled trial design
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2019

First Posted

July 17, 2019

Study Start

September 19, 2019

Primary Completion

September 30, 2022

Study Completion

August 31, 2025

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(12)