MOTIV Bioresorbable Scaffold in BTK Artery Disease
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|ClinicalTrials.gov Identifier: NCT03987061|
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease Critical Limb Ischemia||Device: MOTIV BVS||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Physician-initiated Trial Investigating the MOTIV Bioresorbable Scaffold for the Treatment of Below-The-Knee Artery Disease|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||July 1, 2021|
Experimental: MOTIV bioresorbable vascular scaffold
MOTIV bioresorbable vascular scaffold for below-the-knee artery disease
Device: MOTIV BVS
MOTIVS BVS in below-the-knee artery disease
- efficacy endpoint - Primary Patency rate at 12-months post-op, based on duplex ultrasound and without target lesion revascularization. [ Time Frame: 12 months post-op ]Primary patency rate at 12-months, defined as no evidence of at least 50% restenosis or reocclusion within the originally treated lesion based on color-flow-duplex ultrasound (CFDU) measuring a peak systolic velocity ratio ≤2.5, and/or angiography (left at the discretion of the investigator) without target lesion revascularization (TLR) within 12 months.
- safety endpoint - rate of serious device-related adverse events within 30 days post-op [ Time Frame: 30 days post-op ]
- Technical Success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% [ Time Frame: 1-day post-op ]Technical Success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%
- Primary Patency rate at 1 and 6 months follow-up, based on duplex ultrasound. [ Time Frame: 1 month, 6 months and 12 months post-op ]defined as patients that present without a hemodynamically significant restenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the given follow-up.
- Clinically-driven target lesion revascularization (TLR) at 1, 6 and 12-months [ Time Frame: 1 month, 6 months and 12 months post-op ]Clinically-driven (drop in 1 Rutherford Classification) target lesion revascularization (TLR) is defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the device/PTA edge, at 1, 6 and 12-month follow-up.
- Limb-Salvage rate at 1, 6 and 12 months, defined as absence of major amputation. [ Time Frame: 1 month, 6 months and 12 months post-op ]Major amputation is defined as amputation at or above the ankle, as opposed to minor amputation, being an amputation at or below metatarsal level, preserving functionality of the foot.
- Clinical success at follow-up is defined as an improvement of Rutherford classification at 1 day and 1, 6 and 12 month follow-up of one class or more as compared to the pre-procedural Rutherford Classification. [ Time Frame: 1 day post-op and 1 month, 6 months and 12 months post-op ]
- Serious adverse events during the study (within 12 months post-op) [ Time Frame: within 12 months post-op ]Serious adverse events as defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.
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): NCT03987061
|Contact: Jeroen Wautersemail@example.com|
|Study Director:||Giovanni Torsello, Prof. Dr.||Foundation for Cardiovascular Research and Education|