Back to resultsMOTIV Bioresorbable Scaffold in BTK Artery Disease (MOTIV BVS BTK)
Primary Purpose
Peripheral Arterial Disease, Critical Limb Ischemia
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MOTIV BVS
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility Criteria
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:
- short de novo or Restenotic lesion after PTA or
- a short residual flow-limiting dissection or restenosis after PTA of a longer lesion
Exclusion Criteria:
- The reference segment diameter is not suitable for the available stent design
- Untreated flow-limiting aortoiliac stenotic disease
- Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment.
- Any previous surgery in the target vessel
- Aneurysm located at the target vessel
- Non-atherosclerothic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
- Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 2-year life expectancy.
- Major distal amputation (above the transmetatarsal) in the study or non-study limb.
- Septicemia or bacteremia
- Any previously known coagulation disorder, including hypercoagulability
- Contraindication to anticoagulation or antiplatelet therapy
- Known allergies to scaffold or scaffold components
- Known allergies to contrast media that cannot be adequately premedicated prior to the study procedure
- Patient with known hypersensitivity to heparin-induced thrombocytopenia (HIT) type II
- Currently participating in another clinical research trial
Sites / Locations
- Hospital Floridsdorf
- Klinikum Hochsauerland
- Bad Oeyhausen Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie
- Medizinische Versorgungszentren GmbH
- University Hospital Leipzig, Angiology
- Katholisches Klinikum Mainz; Akademisches Lehrkrankenhaus der Johannes Gutenberg-Universität Mainz
- St. Franziskus-Hospital
- University Hospital Münster, Angiology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MOTIV bioresorbable vascular scaffold
Arm Description
MOTIV bioresorbable vascular scaffold for below-the-knee artery disease
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Technical Success
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 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.
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
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03987061
Brief Title
MOTIV Bioresorbable Scaffold in BTK Artery Disease
Acronym
MOTIV BVS BTK
Official Title
Physician-initiated Trial Investigating the MOTIV™ Bioresorbable Scaffold (Reva Medical) for the Treatment of Below-The-Knee Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Sabrina Overhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Critical Limb Ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Application of the MOTIV Bioresorbable Scaffold in Patients with Lesions Below-The-Knee (BTK)
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MOTIV bioresorbable vascular scaffold
Arm Type
Experimental
Arm Description
MOTIV bioresorbable vascular scaffold for below-the-knee artery disease
Intervention Type
Device
Intervention Name(s)
MOTIV BVS
Intervention Description
MOTIVS BVS in below-the-knee artery disease
Primary Outcome Measure Information:
Title
efficacy endpoint - Primary Patency rate at 12-months post-op
Description
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
Title
safety endpoint - rate of serious device-related adverse events within 30 days post-op
Description
Proportion of subjects who experience serious device-related adverse events within 30 days post-procedure.
Time Frame
30 days post-op
Secondary Outcome Measure Information:
Title
Technical Success
Description
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
Title
Primary Patency rate at follow-up visits
Description
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
Title
Clinically-driven target lesion revascularization (TLR) at 1, 6, 12, 24 and 36-months
Description
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
Title
Limb-Salvage rate at follow-up visits
Description
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
Title
Clinical success at follow-up visits
Description
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
Title
Serious adverse events during the study (within 36 months post-op)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
short de novo or Restenotic lesion after PTA or
a short residual flow-limiting dissection or restenosis after PTA of a longer lesion
Exclusion Criteria:
The reference segment diameter is not suitable for the available stent design
Untreated flow-limiting aortoiliac stenotic disease
Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment.
Any previous surgery in the target vessel
Aneurysm located at the target vessel
Non-atherosclerothic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 2-year life expectancy.
Major distal amputation (above the transmetatarsal) in the study or non-study limb.
Septicemia or bacteremia
Any previously known coagulation disorder, including hypercoagulability
Contraindication to anticoagulation or antiplatelet therapy
Known allergies to scaffold or scaffold components
Known allergies to contrast media that cannot be adequately premedicated prior to the study procedure
Patient with known hypersensitivity to heparin-induced thrombocytopenia (HIT) type II
Currently participating in another clinical research trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Torsello, Prof. Dr.
Organizational Affiliation
Foundation for Cardiovascular Research and Education
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Floridsdorf
City
Vienna
Country
Austria
Facility Name
Klinikum Hochsauerland
City
Arnsberg
Country
Germany
Facility Name
Bad Oeyhausen Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie
City
Bad Oeynhausen
Country
Germany
Facility Name
Medizinische Versorgungszentren GmbH
City
Berlin
Country
Germany
Facility Name
University Hospital Leipzig, Angiology
City
Leipzig
Country
Germany
Facility Name
Katholisches Klinikum Mainz; Akademisches Lehrkrankenhaus der Johannes Gutenberg-Universität Mainz
City
Mainz
Country
Germany
Facility Name
St. Franziskus-Hospital
City
Münster
Country
Germany
Facility Name
University Hospital Münster, Angiology
City
Münster
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MOTIV Bioresorbable Scaffold in BTK Artery Disease
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