Iliac Artery StenosisNCT04023370
Evaluation of the Efficacy and Safety of the Application of BeGraft Peripheral Stent Graft System
A study testing Treatment of primary iliac artery stenosis and/or occlusive lesions in people with Iliac Artery Stenosis, run by Bentley InnoMed GmbH at 12 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iliac Artery Stenosis
- What is being tested?
- Treatment of primary iliac artery stenosis and/or occlusive lesions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 12 sitesChina
- Study dates
- 19 Sep 2019to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Beijing Hospital
Beijing
Peking University First Hospital
Beijing
Peking University People's Hospital
Beijing
Peking University Third Hospital
Beijing
Shanghai Ninth People's Hospital
Shanghai
Suzhou Municipal Hospital
Suzhou
The Second Affiliated Hospital of Soochow University
Suzhou
General Hospital of Tianjin Medical University
Tianjin
The Second Hospital of Tianjin Medical University
Tianjin
Tianjin First Center Hospital
Tianjin
The Central Hospital of Wuhan
Wuhan
The First Hospital of Zhejiang Province
Zhejiang
About this study
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
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
Read the 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
- Being tested
- Treatment of primary iliac artery stenosis and/or occlusive lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of primary iliac artery stenosis and/or occlusive lesionsDevice
Stent implantation
| Study group | Role | What they receive |
|---|---|---|
| BeGraft Peripheral Stent Graft System | Experimental | Covered stent Receives: Device: Treatment of primary iliac artery stenosis and/or occlusive lesions |
| Bare metal stent system | Active comparator | bare metal stent Receives: Device: Treatment of primary iliac artery stenosis and/or occlusive lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 month
Secondary outcomes (1)
Device/Surgical success rate
Stent placement and integrity
Measured: 30 days, 6 months and 12 months following surgery, and then once a year from the 2nd to 5th year following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start19 Sep 2019
- Primary completion30 Sep 2022
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliac Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multi-centre, randomised controlled trial design
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bentley InnoMed GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Micro Medical Devices Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023370
- Sponsor's protocol ID
- CT02-01 BGP-China
- Status last verified
- Oct 2024
- First submitted
- 15 Jul 2019
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04023370
- Acronym / sponsor ID
- CT02-01 BGP-China
- Conditions
- Iliac Artery Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Bentley InnoMed GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Micro Medical Devices Co., Ltd.
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multi-centre, randomised controlled trial design
| Arm | Type | Receives |
|---|---|---|
| BeGraft Peripheral Stent Graft System | Experimental | Device: Treatment of primary iliac artery stenosis and/or occlusive lesionsCovered stent |
| Bare metal stent system | Active comparator | Device: Treatment of primary iliac artery stenosis and/or occlusive lesionsbare metal stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of primary iliac artery stenosis and/or occlusive lesionsStent implantation | Device | Bare metal stent system, BeGraft Peripheral Stent Graft System |
Primary outcome
Primary patency rate
Time frame: 12 month
The primary patency rate is defined as the absence of restenosis in the treated vessel segment without accompanying target lesion revascularisation (TLR) or amputation.
1 secondary outcome
Device/Surgical success rate
Time frame: 30 days, 6 months and 12 months following surgery, and then once a year from the 2nd to 5th year following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of primary iliac artery stenosis and/or occlusive lesions in people with Iliac Artery Stenosis, run by Bentley InnoMed GmbH at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency rate (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.