Physician-Initiated Trial Investigating the BeGraft Peripheral Stent Graft System
|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.
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|