Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOTIV bioresorbable vascular scaffold | Experimental | MOTIV bioresorbable vascular scaffold for below-the-knee artery disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOTIV BVS | Device | MOTIVS BVS in below-the-knee artery disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 30 days post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | Technical Success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% | 1-day post-op |
| Primary Patency rate at follow-up visits |
Not provided
Inclusion Criteria:
Patient is willing to comply with specified follow-up evaluations at the specified times
Patient presenting with rest pain or minor tissue loss (Rutherford classification from 4 to 5)
Patient is >18 years old
Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study - Patient has a projected life-expectancy of at least 24-months
Patient is eligible for treatment with the MOTIV™ Bioresorbable Scaffold
Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
De novo lesion or Restenotic lesion after PTA in the infrapopliteal arteries, suitable for endovascular therapy
Target vessel diameter visually estimated to be ≥2.5mm and ≤3.50mm
Guidewire and delivery system successfully traversed the lesion
Total target lesion is maximally 100mm
Definition of Target Lesion is:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Giovanni Torsello, Prof. Dr. | Foundation for Cardiovascular Research and Education | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Floridsdorf | Vienna | Austria | ||||
| Klinikum Hochsauerland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Application of the MOTIV Bioresorbable Scaffold in Patients with Lesions Below-The-Knee (BTK)
Not provided
Not provided
Not provided
Not provided
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.
| 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 | 1 month, 6 months, 12 months, 24 months and 36 months post-op |
| 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. | 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. | 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. | within 36 months post-op |
| Arnsberg |
| Germany |
| Bad Oeyhausen Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie | Bad Oeynhausen | Germany |
| Medizinische Versorgungszentren GmbH | Berlin | Germany |
| 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 |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |