The objective of this clinical evaluation is to evaluate the immediate and long-term (up to 36 months) outcome of the MOTIV™ Bioresorbable Scaffold (Reva Medical) in a controlled prospective investigation for the treatment of patients with rest pain or minor tissue loss (CLI) due to the presence of lesions of max 100mm in length at the level of the below-the-knee arteries.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
MOTIVS BVS in below-the-knee artery disease
Hospital Floridsdorf
Vienna, Austria
Klinikum Hochsauerland
Arnsberg, Germany
Bad Oeyhausen Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie
Bad Oeynhausen, Germany
Medizinische Versorgungszentren GmbH
Berlin, Germany
efficacy endpoint - Primary Patency rate at 12-months post-op
Primary patency 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.
Time frame: 12 months post-op
safety endpoint - rate of serious device-related adverse events within 30 days post-op
Proportion of subjects who experience serious device-related adverse events within 30 days post-procedure.
Time frame: 30 days post-op
Technical Success
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
Primary Patency rate at follow-up visits
Primary patency rate 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.
Time frame: 1 month, 6 months, 12 months, 24 months and 36 months post-op
Clinically-driven target lesion revascularization (TLR) at 1, 6, 12, 24 and 36-months
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
Time frame: 1 month, 6 months, 12 months, 24 months and 36 months post-op
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University Hospital Leipzig, Angiology
Leipzig, Germany
Katholisches Klinikum Mainz; Akademisches Lehrkrankenhaus der Johannes Gutenberg-Universität Mainz
Mainz, Germany
St. Franziskus-Hospital
Münster, Germany
University Hospital Münster, Angiology
Münster, Germany
Limb-Salvage rate at follow-up visits
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.
Time frame: 1 month, 6 months, 12 months, 24 months and 36 months post-op
Clinical success at follow-up visits
Clinical success at follow-up is defined as an improvement of Rutherford classification at 1 day and 1-, 6-, 12-, 24- and 36-months 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, 12 months, 24 months and 36 months post-op
Serious adverse events during the study (within 36 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.
Time frame: within 36 months post-op