Physician-Initiated Trial Investigating the BeGraft Peripheral Stent Graft System
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|ClinicalTrials.gov Identifier: NCT02211716|
Recruitment Status : Completed
First Posted : August 7, 2014
Last Update Posted : January 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Vascular Disease||Device: BeGraft Peripheral Stent Graft System||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Physician-Initiated PMCF Trial Investigating the BeGraft Peripheral Stent Graft System for the Treatment of Iliac Lesions|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Patient's treated with the BeGraft PMCF Stent Graft System from Bentley Innomed for the treatment of iliac lesions.
Device: BeGraft Peripheral Stent Graft System
- Primary patency at 12 months [ Time Frame: 12 months ]Defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR) within 12 months.
- Primary patency rate at 1- and 6-month follow-up [ Time Frame: 1 and 6 months ]Patients that present wihout a hemodynamically significant stenosis at the target area on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without prior TLR.
- Stent graft occlusion rate at pre-discharge, 1-, 6- and 12-month follow-up [ Time Frame: 1 day post-op, 1, 6 and 12 months ]The ratio of patients where the implanted stent graft has been occluded.
- Ankle Brachial Index (ABI) at 1-, 6- and 12-month follow-up [ Time Frame: 1, 6 and 12 months ]The ABI measurement at 1, 6 and 12 months compared to the baseline ABI measurement.
- Performance success rate at baseline [ Time Frame: 1 day post-op ]
Defined as a composite of:
- successful in sealing acute perforation or rupture
- successful in treating aneurysms and fistulae
- restoration of blood flow
- In-stent restenosis rate at 1-, 6- and 12-month follow-up [ Time Frame: 1, 6 and 12 months ]The ratio of patients experiencing in-stent restenosis at the different follow-ups.
- Freedom from Target Lesion Revascularization (TLR) at 1-, 6- and 12-months [ Time Frame: 1, 6 and 12 months ]Defined as freedom from a repeat intervention to maintain or re-estabish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge.
- Serious Adverse Avents [ Time Frame: up to 12 months ]
- Technical success [ Time Frame: 1 day post-op ]Defined as the ability to achieve final residual angiographic stenosis no greater than 30%.
- Amputation rate at 1-, 6- and 12-month follow-up [ Time Frame: 1, 6 and 12 months ]Defined as any amputation above the knee.
- Clinical success at 1-, 6- and 12-month follow-up [ Time Frame: 1, 6 and 12 months ]Defined as an improvement of Rutherford classification at 1-, 6- and 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02211716
|Aalst, Belgium, 9300|
|Bonheiden, Belgium, 2820|
|Dendermonde, Belgium, 9200|
|RZ Heilig Hart Tienen|
|Tienen, Belgium, 3300|
|Principal Investigator:||Koen Deloose, MD||Flanders Medical Research Program|