Peripheral Arterial DiseaseBeGraft+PMCFNCT03286361
Clinical Trial Investigating the BeGraft Peripheral Plus Stent Graft System for Iliac Lesion Treatment
A study testing BeGraft Peripheral Plus Stent Graft System in people with Peripheral Arterial Disease, run by ID3 Medical at 9 sites in 2 countries.
Trial summary
The BeGraft Plus PMCF Trial investigates the efficacy of the BeGraft Peripheral Plus Stent Graft System in the treatment of iliac stenotic or occlusive lesions (TASC A, B, C and D). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- BeGraft Peripheral Plus Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 29 Nov 2017to Apr 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
None listed.
Who cannot join
- PTA is technically not possible (not feasible to access the lesion or a defect with the guidewire or balloon catheter)
- Presence of an aneurysm immediately adjacent to the site of stent implantation
- Stenosis distal to the site of stent implantation
- Lesions in or adjacent to essential collaterals(s)
- Lesions in locations subject to external compression
- Heavily calcified lesions resistant to percutaneous transluminal angioplasty (PTA)
Show all 36Show fewer
- Patients with diffuse distal disease resulting in poor stent outflow
- Patients with a history of coagulation disorders
- Patients with aspirin allergy or bleeding complications and patients unable or unwilling to tolerate anticoagulant/antiplatelet therapy and/or non-responders to anticoagulant/antiplatelet therapy
- Fresh thrombus formation
- Patients with known hypersensitivity to the stent material (L605) and or polytetrafluoroethylene (PTFE)
- Previously implanted stent(s) at the same lesion site
- Reference segment diameter is not suitable for the available stent design
- Untreatable lesion located at the distal outflow arteries
- Use of alternative therapy (e.g. atherectomy, cutting balloon, drug-coated balloon (DCB), laser, radiation therapy) as part of the index procedure
- Patients refusing treatment
- Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
- Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
- Patients with a history of prior life-threatening contrast medium reaction
- Patients with uncorrected bleeding disorders
- Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
- Life expectancy of less than twelve months
- Any planned surgical intervention/procedure within 30 days of the study procedure
- Any patient considered to be hemodynamically unstable at onset of procedure
- Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
- The target lesion is either a modified TASC-II class B, C or D lesion with aortic or common femoral lesion involvement:
- o Type B lesions
- Short (≤3 cm) stenosis of infrarenal aorta
- o Type C lesions
- Unilateral External Iliac Artery stenosis extending into the Common Femoral Artery
- Unilateral External Iliac Artery occlusion that involves the origins of the Internal Iliac and/or Common Femoral Artery
- Heavily calcified unilateral External Iliac Artery occlusion with or without involvement of origins of the Internal Iliac and/or Common Femoral Artery
- o Type D lesions
- Infra-renal aortoiliac occlusion
- Iliac stenoses in patients with an Abdominal Aortic Aneurysm (AAA) requiring treatment and not amenable to endograft placement or other lesions requiring open aortic or iliac surgery
- Diffuse multiple stenoses involving the unilateral Common Iliac, External Iliac and Common Femoral Artery
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Belgium8 sites
O.L.V. Hospital
Aalst, 9300
ZNA
Antwerp
Imelda Hospital
Bonheiden, 2820
A.Z. Sint-Blasius
Dendermonde, 9200
ZOL
Genk
az Groeninge
Kortrijk
RZ Heilig Hart
Tienen
AZ Jan Portaels
Vilvoorde
About this study
Official title: Belgo-France Physician-initiated Trial Investigating the BeGraft Peripheral Plus Stent Graft System for the Treatment of Iliac Lesions (TASC A, B, C and D)
The BeGraft Plus PMCF Trial investigates the efficacy of the BeGraft Peripheral Plus Stent Graft System in the treatment of iliac stenotic or occlusive lesions (TASC A, B, C and D). An expected total of 20 patients with TASC A and B lesions and an expected total of 50 patients with TASC C and D lesions will be treated. The lesion is located within the native Iliac arteries. Prior to stenting with the BeGraft Peripheral Plus Stent Graft System, pre-dilatation can be performed according to the physician's discretion. Also post-dilatation can be performed according to the physician's discretion. Patients will be invited for a follow-up visit at 1, 6, 12, 24 and 36- month post-procedure. The primary efficacy endpoint of the study is the primary patency at 12 months. The primary safety endpoint is the freedom of periprocedural Serious Adverse Events (SAEs). Secondary endpoint include primary patency rate at 1, 6, 24, and 36-month, stent graft occlusion rate at pre-discharge,1, 6, 24, and 36 month follow-up, anke-brachial index (ABI) at 1, 6, 12, 24 and 36-month follow-up, amputation rate at 1, 6, 12, 24 and 36-month follow-up, performance success rate, freedom from target lesion revascularization (TLR), technical success and clinical success at 1, 6, 12, 24 and 36-month follow-up. The extension in the Begraft Plus protocol is being made to evaluate the long-term safety and efficacy of the BeGraft Peripheral Plus Stent Graft.
Read the detailed description
The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term safety and efficacy of the BeGraft Peripheral Plus Stent Graft System in clinical settings post CE-certification when used according to the indications of the IFU with focus on the treatment of complex TASC A, B, C and D iliac lesions.
Patients will be selected based on the investigator's assessment, evaluation of the underlying disease and the eligibility criteria. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required testing or from completing the study. Patients should also be geographically stable, willing and able to cooperate in this clinical study and remain available for long-term follow-up. A patient is considered enrolled in the study after obtaining the patients informed consent, if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion.
Prior to the index procedure the following tests and clinical data will be collected: informed consent for data collection, demographics, medical history, medication record, physical examination, clinical category of chronic limb ischemia (Rutherford category) and resting ankle-brachial index (ABI).
During the procedure, the vascular access can be achieved to the investigator's standard clinical practice. After successful lesion passage, diagnostic angiography of the lesion area and distal run-off is performed and angiographic measurements (vessel diameter, percentage stenosis and lesion length) are collected. At the physician's discretion, the patient receives at least 1 BeGraft Peripheral Plus Stent Graft System. Pre- and post-dilatation are according to the physician's discretion. No other adjunctive therapies (atherectomy, laser) are allowed. The complete iliac vasculature should be treated in one single session, staged interventions are not allowed. All outflow-limiting lesions must be treated according to the hospital treatment standard.
The regular follow-ups are necessary to monitor the condition of the patient and the stent/procedure. Patients will be invited for a follow-up visit at 1, 6, 12, 24 and 36 months after the index procedure. The following data will be collected during these follow-up visit: medication record, physical examination, rutherford categorization, ABI and color flow doppler ultrasound.
- Conditions
- Peripheral Arterial Disease
- Being tested
- BeGraft Peripheral Plus Stent Graft System
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeGraft Peripheral Plus Stent Graft SystemDevice
Patients will be treated with the BeGraft Peripheral Plus Stent Graft System
| Study group | Role | What they receive |
|---|---|---|
| BeGraft Peripheral + Stent Graft System | Experimental | Patients treated with the BeGraft Peripheral Plus Stent Graft System Receives: Device: BeGraft Peripheral Plus Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency at 12 months
Freedom from >50% restenosis as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no target lesion revascularization within 12 months.
Measured: 12 months
Periprocedural Serious Adverse Events (SAEs)
Periprocedural SAEs up to 30-days post-procedure, as defined according to the International Organization of Standardization (ISO) guidelines: ISO 14155:2011
Measured: 30-days post-procedure
Secondary outcomes (8)
Primary patency rate
Freedom from >50% restenosis as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no target lesion revascularization within 12 months.
Measured: 1-, 6-, 24- and 36-months post-procedure
Stent graft occlusion rate
Occlusion of the stent graft system
Measured: Pre-discharge, 1-, 6- 12-, 24-, and 36-month follow-up
Ankle-brachial index (ABI)
ABI at follow-up compared with the baseline ABI
Measured: 1-, 6-, 12-, 24-, and 36-month follow-up
Amputation rate
Any amputation above the knee
Measured: 1-, 6-, 12-, 24-, and 36-month follow-up
Performance success rate
Successful in sealing acute perforation or rupture, in treating aneurysms and fistulae of restoration of blood flow
Measured: Baseline
Freedom from target lesion revascularization (TLR)
Freedom from a repeated intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge
Measured: 1-, 6-, 12-, 24-, and 36-month follow-up
Technical success
Ability to achieve final residual angiographic stenosis no greater than 30%
Measured: Index procedure
Clinical success
Improvement of Rutherford classification compared to the pre-procedure Rutherford classification
Measured: 1-, 6-, 12-, 24-, and 36-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start29 Nov 2017
- Primary completion24 Apr 2023
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ID3 Medical
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Koen Deloose, MD, Study director, ID3 Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286361
- Sponsor's protocol ID
- ID3-20170711
- Acronym
- BeGraft+PMCF
- Status last verified
- Sep 2024
- First submitted
- 15 Sep 2017
- Last updated
- 16 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 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belgo-France Physician-initiated Trial Investigating the BeGraft Peripheral Plus Stent Graft System for the Treatment of Iliac Lesions (TASC A, B, C and D)
- ClinicalTrials.gov ID
- NCT03286361
- Acronym / sponsor ID
- BeGraft+PMCF / ID3-20170711
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- ID3 MedicalUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- Apr 2025 (estimated)
- First posted
- 18 Sep 2017 (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 BeGraft Plus PMCF Trial investigates the efficacy of the BeGraft Peripheral Plus Stent Graft System in the treatment of iliac stenotic or occlusive lesions (TASC A, B, C and D). An expected total of 20 patients with TASC A and B lesions and an expected total of 50 patients with TASC C and D lesions will be treated. The lesion is located within the native Iliac arteries. Prior to stenting with the BeGraft Peripheral Plus Stent Graft System, pre-dilatation can be performed according to the physician's discretion. Also post-dilatation can be performed according to the physician's discretion. Patients will be invited for a follow-up visit at 1, 6, 12, 24 and 36- month post-procedure. The primary efficacy endpoint of the study is the primary patency at 12 months. The primary safety endpoint is the freedom of periprocedural Serious Adverse Events (SAEs). Secondary endpoint include primary patency rate at 1, 6, 24, and 36-month, stent graft occlusion rate at pre-discharge,1, 6, 24, and 36 month follow-up, anke-brachial index (ABI) at 1, 6, 12, 24 and 36-month follow-up, amputation rate at 1, 6, 12, 24 and 36-month follow-up, performance success rate, freedom from target lesion revascularization (TLR), technical success and clinical success at 1, 6, 12, 24 and 36-month follow-up. The extension in the Begraft Plus protocol is being made to evaluate the long-term safety and efficacy of the BeGraft Peripheral Plus Stent Graft.
Detailed description
The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term safety and efficacy of the BeGraft Peripheral Plus Stent Graft System in clinical settings post CE-certification when used according to the indications of the IFU with focus on the treatment of complex TASC A, B, C and D iliac lesions.
Patients will be selected based on the investigator's assessment, evaluation of the underlying disease and the eligibility criteria. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required testing or from completing the study. Patients should also be geographically stable, willing and able to cooperate in this clinical study and remain available for long-term follow-up. A patient is considered enrolled in the study after obtaining the patients informed consent, if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion.
Prior to the index procedure the following tests and clinical data will be collected: informed consent for data collection, demographics, medical history, medication record, physical examination, clinical category of chronic limb ischemia (Rutherford category) and resting ankle-brachial index (ABI).
During the procedure, the vascular access can be achieved to the investigator's standard clinical practice. After successful lesion passage, diagnostic angiography of the lesion area and distal run-off is performed and angiographic measurements (vessel diameter, percentage stenosis and lesion length) are collected. At the physician's discretion, the patient receives at least 1 BeGraft Peripheral Plus Stent Graft System. Pre- and post-dilatation are according to the physician's discretion. No other adjunctive therapies (atherectomy, laser) are allowed. The complete iliac vasculature should be treated in one single session, staged interventions are not allowed. All outflow-limiting lesions must be treated according to the hospital treatment standard.
The regular follow-ups are necessary to monitor the condition of the patient and the stent/procedure. Patients will be invited for a follow-up visit at 1, 6, 12, 24 and 36 months after the index procedure. The following data will be collected during these follow-up visit: medication record, physical examination, rutherford categorization, ABI and color flow doppler ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BeGraft Peripheral + Stent Graft System | Experimental | Device: BeGraft Peripheral Plus Stent Graft SystemPatients treated with the BeGraft Peripheral Plus Stent Graft System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (36 listed)
- PTA is technically not possible (not feasible to access the lesion or a defect with the guidewire or balloon catheter)
- Presence of an aneurysm immediately adjacent to the site of stent implantation
- Stenosis distal to the site of stent implantation
- Lesions in or adjacent to essential collaterals(s)
- Lesions in locations subject to external compression
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 |
|---|---|---|
| BeGraft Peripheral Plus Stent Graft SystemPatients will be treated with the BeGraft Peripheral Plus Stent Graft System | Device | BeGraft Peripheral + Stent Graft System |
Primary outcome
Primary patency at 12 months
Time frame: 12 months
Freedom from >50% restenosis as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no target lesion revascularization within 12 months.
Periprocedural Serious Adverse Events (SAEs)
Time frame: 30-days post-procedure
Periprocedural SAEs up to 30-days post-procedure, as defined according to the International Organization of Standardization (ISO) guidelines: ISO 14155:2011
8 secondary outcomes
Primary patency rate
Time frame: 1-, 6-, 24- and 36-months post-procedure
Stent graft occlusion rate
Time frame: Pre-discharge, 1-, 6- 12-, 24-, and 36-month follow-up
Ankle-brachial index (ABI)
Time frame: 1-, 6-, 12-, 24-, and 36-month follow-up
Amputation rate
Time frame: 1-, 6-, 12-, 24-, and 36-month follow-up
Performance success rate
Time frame: Baseline
Freedom from target lesion revascularization (TLR)
Time frame: 1-, 6-, 12-, 24-, and 36-month follow-up
Technical success
Time frame: Index procedure
Clinical success
Time frame: 1-, 6-, 12-, 24-, and 36-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 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.
Koen Deloose, MD study director
ID3 Medical
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BeGraft Peripheral Plus Stent Graft System in people with Peripheral Arterial Disease, run by ID3 Medical at 9 sites in 2 countries.
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 0 inclusion and 36 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 16 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 9 sites in Belgium, France. 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 at 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. 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 16 Oct 2024.