An interventional study of BeGraft Peripheral Plus Stent Graft System in Peripheral Arterial Disease, sponsored by ID3 Medical. Active, not recruiting at 9 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by ID3 Medical · Not applicable, Interventional, and Treatment
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.
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.
General inclusion criteria
Angiographic inclusion criteria:
The target lesion is either a modified TASC-II class A, B, C or D lesion with one of the listed specifications:
o Type A lesions
Unilateral or bilateral single short (≤3 cm) stenosis of the External Iliac Artery
o Type B lesions
Unilateral External Iliac Artery occlusion not involving the origins of Internal Iliac Artery or Common Iliac Artery
o Type C lesions
Bilateral External Iliac Artery stenoses 3-10 cm long not extending into the Common Femoral Artery
o Type D lesions
Exclusion Criteria:
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
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
Patients treated with the BeGraft Peripheral Plus Stent Graft System
Device: BeGraft Peripheral Plus Stent Graft System
Patients will be treated with the BeGraft Peripheral Plus Stent Graft System
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.
Time frame: 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
Time frame: 30-days post-procedure
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.
Time frame: 1-, 6-, 24- and 36-months post-procedure
Stent graft occlusion rate
Occlusion of the stent graft system
Time frame: Pre-discharge, 1-, 6- 12-, 24-, and 36-month follow-up
Ankle-brachial index (ABI)
ABI at follow-up compared with the baseline ABI
Time frame: 1-, 6-, 12-, 24-, and 36-month follow-up
Amputation rate
Any amputation above the knee
Time frame: 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
Time frame: 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
Time frame: 1-, 6-, 12-, 24-, and 36-month follow-up
Technical success
Ability to achieve final residual angiographic stenosis no greater than 30%
Time frame: Index procedure
Clinical success
Improvement of Rutherford classification compared to the pre-procedure Rutherford classification
Time frame: 1-, 6-, 12-, 24-, and 36-month follow-up
Plan to share: No
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This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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