Peripheral Arterial DiseaseMOTIV BVS BTKNCT03987061
MOTIV Bioresorbable Scaffold in BTK Artery Disease
A study testing MOTIV BVS in people with Peripheral Arterial Disease and Critical Limb Ischemia, run by Dr. Sabrina Overhagen at 8 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Critical Limb Ischemia
- What is being tested?
- MOTIV BVS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 5 Sep 2019to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Germany7 sites
Klinikum Hochsauerland
Arnsberg
Bad Oeyhausen Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie
Bad Oeynhausen
Medizinische Versorgungszentren GmbH
Berlin
University Hospital Leipzig, Angiology
Leipzig
Katholisches Klinikum Mainz; Akademisches Lehrkrankenhaus der Johannes Gutenberg-Universität Mainz
Mainz
St. Franziskus-Hospital
Münster
University Hospital Münster, Angiology
Münster
About this study
Official title: Physician-initiated Trial Investigating the MOTIV™ Bioresorbable Scaffold (Reva Medical) for the Treatment of Below-The-Knee Artery Disease
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.
- Being tested
- MOTIV BVS
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOTIV BVSDevice
MOTIVS BVS in below-the-knee artery disease
| Study group | Role | What they receive |
|---|---|---|
| MOTIV bioresorbable vascular scaffold | Experimental | MOTIV bioresorbable vascular scaffold for below-the-knee artery disease Receives: Device: MOTIV BVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days post-op
Secondary outcomes (6)
Technical Success
Technical Success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within 36 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start5 Sep 2019
- Primary completion1 Jul 2022
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Application of the MOTIV Bioresorbable Scaffold in Patients with Lesions Below-The-Knee (BTK)
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Sabrina Overhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Sabrina Overhagen, FCRE (Foundation for Cardiovascular Research and Education)
- Investigators
- Giovanni Torsello, Prof. Dr., Study director, Foundation for Cardiovascular Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987061
- Sponsor's protocol ID
- FCRE-190131
- Acronym
- MOTIV BVS BTK
- Status last verified
- Mar 2023
- First submitted
- 12 Jun 2019
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician-initiated Trial Investigating the MOTIV™ Bioresorbable Scaffold (Reva Medical) for the Treatment of Below-The-Knee Artery Disease
- ClinicalTrials.gov ID
- NCT03987061
- Acronym / sponsor ID
- MOTIV BVS BTK / FCRE-190131
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Dr. Sabrina OverhagenUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Application of the MOTIV Bioresorbable Scaffold in Patients with Lesions Below-The-Knee (BTK)
| Arm | Type | Receives |
|---|---|---|
| MOTIV bioresorbable vascular scaffold | Experimental | Device: MOTIV BVSMOTIV bioresorbable vascular scaffold for below-the-knee artery disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOTIV BVSMOTIVS BVS in below-the-knee artery disease | Device | MOTIV bioresorbable vascular scaffold |
Primary outcome
efficacy endpoint - Primary Patency rate at 12-months post-op
Time frame: 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
Time frame: 30 days post-op
Proportion of subjects who experience serious device-related adverse events within 30 days post-procedure.
6 secondary outcomes
Technical Success
Time frame: 1-day post-op
Primary Patency rate at follow-up visits
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
Time frame: 1 month, 6 months, 12 months, 24 months and 36 months post-op
Limb-Salvage rate at follow-up visits
Time frame: 1 month, 6 months, 12 months, 24 months and 36 months post-op
Clinical success at follow-up visits
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)
Time frame: within 36 months post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Torsello, Prof. Dr. study director
Foundation for Cardiovascular Research and Education
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOTIV BVS in people with Peripheral Arterial Disease and Critical Limb Ischemia, run by Dr. Sabrina Overhagen at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy endpoint - Primary Patency rate at 12-months post-op (time frame: 12 months post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.