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MOTIV BTK Randomized Controlled Trial

Primary Purpose

Critical Limb Ischemia

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MOTIV Sirolimus-Eluting Bioresorbable Scaffold
Percutaneous Transluminal Angioplasty (PTA) Device
Sponsored by
REVA Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Limb Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical Inclusion Criteria

Subjects must meet all of the following criteria to be eligible for enrollment in the trial:

  1. Subject is at least 18 years of age.
  2. Subject presents with symptomatic CLI classified as Rutherford category 4 or 5.
  3. Subject agrees to comply with all-protocol specified procedures and follow-up assessments.
  4. Subject or subject's legal representative signs an IRB/EC approved informed consent form prior to study participation.

Angiographic Inclusion Criteria

Subjects must meet the following criteria to be eligible for participation in the study:

  1. Significant stenosis (>70% diameter stenosis by visual estimate) of one or two native infrapopliteal lesions; if two lesions, each lesion should be in a separate infrapopliteal vessel in the same limb. Unstented restenotic lesions are permitted.
  2. Target vessel diameter between 2.5 mm and 3.75 mm and able to be treated with the available device size matrix.
  3. Each target lesion is treatable by a maximum of 3 scaffolds, and all target lesions(s) combined must be treatable by a maximum of 4 scaffolds.
  4. Total scaffold length among all target lesions must not exceed 120 mm (total sirolimus drug dose of 720 µg).
  5. Target lesion(s) must be at least 4 cm above the ankle joint
  6. Target lesion(s) are located in an area that may be stented without blocking access to patent main branches.
  7. A patent inflow artery from the aorta to the target lesion free from significant stenosis (≥50% diameter stenosis by visual estimate) must be present, as confirmed by angiography.
  8. Significant lesions (≥50% diameter stenosis) in inflow arteries must be treated successfully (per physician's assessment) using standard of care treatment prior to enrollment; inflow lesion treatment may be performed during the index procedure.
  9. Target vessel(s) reconstitute(s) at or above the ankle or displays normal terminal branching with inline flow to at least one patent (<50% diameter stenosis by visual assessment) outflow vessel.

Exclusion Criteria:

Clinical Exclusion Criteria

Subjects will be excluded if any of the following criteria apply:

  1. Subject has severe medical comorbidities or other medical, social or psychological condition that could limit subject's ability to participate in the study or is associated with a life expectancy of less than 1 year.
  2. Subject has documented history of stroke within 3 months prior to the procedure.
  3. Subject has history of MI, within 30 days prior to the planned index procedure.
  4. Subjects with renal failure (estimated Glomerular Filtration Rate [eGFR] < 30 ml/min).
  5. Subject has non-atherosclerotic disease resulting in occlusion (e.g., embolism, Buerger's disease, vasculitis).
  6. Subject presents with CLI classified as Rutherford category 6.
  7. Subject has acute limb ischemia, defined as symptom onset occurring less than 14 days prior to the index procedure with associated loss of sensation or motor function.
  8. Subject had a major amputation that occurred less than one year prior to enrollment and subject is not independently ambulating.
  9. Subject has a planned major amputation (of either leg).
  10. Subject has had, or currently requires, surgical revascularization in the target vessel.
  11. Subject has a planned use of adjunctive primary treatment modalities (e.g., radiation therapy, stents) in below-the-knee vessels; plaque modification technology such as the use of atherectomy, laser or cutting balloons is permitted.
  12. Subject has any systemic infection or immunocompromised state.
  13. Subject has a coagulation disorder, including hypercoagulability; or the subject has contraindication to anticoagulant or antiplatelet therapy.
  14. Subject has a known history of heparin-induced thrombocytopenia (HIT) type II.
  15. Subject has known allergy or sensitivity to scaffold or scaffold components.
  16. Subject has a known allergy or sensitivity to contrast media that cannot be adequately pre-treated.
  17. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
  18. Subject is currently participating in another investigational drug or device clinical study that has not yet met its primary endpoint.

Angiographic Exclusion Criteria

Subjects will be excluded if any of the following criteria apply:

  1. Target lesion(s) with severe calcification (PARC defined).
  2. Target lesion(s) will be subjected to significant bending and axial compression.
  3. Target lesion(s) located in highly tortuous vessels.
  4. Target lesion(s) previously stented (in-stent restenotic lesion).
  5. Target vessel(s) has any other significant lesions (≥50% diameter stenosis by visual assessment) that is not a target lesion.
  6. Target vessel previously treated within 3 months prior to index procedure
  7. Angiographic evidence of thromboembolism in target limb
  8. Inflow-limiting arterial stenoses are unsuccessfully treated or left untreated

Sites / Locations

  • Adventist HealthRecruiting
  • University LeipzigRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MOTIV Sirolimus-Eluting Bioresorbable Scaffold

Percutaneous Transluminal Angioplasty (PTA)

Arm Description

Participants who receive the MOTIV device will be included in this arm

Participants who receive PTA treatment will be included in this arm

Outcomes

Primary Outcome Measures

Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency
Freedom from the composite of above-the-ankle amputation, target lesion occlusion, and clinically driven target lesion revascularization (CD-TLR).
Primary Safety Endpoint: Freedom from Major Adverse Limb Events (MALE) and All-Cause Peri-Operative Death (POD)
Freedom from the composite of all-cause death, above-the-ankle amputation, or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving the infrapopliteal arteries.

Secondary Outcome Measures

Full Information

First Posted
May 31, 2022
Last Updated
October 19, 2022
Sponsor
REVA Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05406622
Brief Title
MOTIV BTK Randomized Controlled Trial
Official Title
A Prospective, Multicenter, Single Blind, Randomized Controlled Trial Evaluating the Safety and Effectiveness of the MOTIV Sirolimus-Eluting Bioresorbable Vascular Scaffold Compared With Plain Balloon Angioplasty for the Treatment of Infrapopliteal Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
March 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
REVA Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
292 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MOTIV Sirolimus-Eluting Bioresorbable Scaffold
Arm Type
Experimental
Arm Description
Participants who receive the MOTIV device will be included in this arm
Arm Title
Percutaneous Transluminal Angioplasty (PTA)
Arm Type
Active Comparator
Arm Description
Participants who receive PTA treatment will be included in this arm
Intervention Type
Device
Intervention Name(s)
MOTIV Sirolimus-Eluting Bioresorbable Scaffold
Intervention Description
Participants will receive the MOTIV device
Intervention Type
Device
Intervention Name(s)
Percutaneous Transluminal Angioplasty (PTA) Device
Intervention Description
Participants will receive PTA treatment
Primary Outcome Measure Information:
Title
Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency
Description
Freedom from the composite of above-the-ankle amputation, target lesion occlusion, and clinically driven target lesion revascularization (CD-TLR).
Time Frame
6 Months
Title
Primary Safety Endpoint: Freedom from Major Adverse Limb Events (MALE) and All-Cause Peri-Operative Death (POD)
Description
Freedom from the composite of all-cause death, above-the-ankle amputation, or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving the infrapopliteal arteries.
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical Inclusion Criteria Subjects must meet all of the following criteria to be eligible for enrollment in the trial: Subject is at least 18 years of age. Subject presents with symptomatic CLI classified as Rutherford category 4 or 5. Subject agrees to comply with all-protocol specified procedures and follow-up assessments. Subject or subject's legal representative signs an IRB/EC approved informed consent form prior to study participation. Angiographic Inclusion Criteria Subjects must meet the following criteria to be eligible for participation in the study: Significant stenosis (>70% diameter stenosis by visual estimate) of one or two native infrapopliteal lesions; if two lesions, each lesion should be in a separate infrapopliteal vessel in the same limb. Unstented restenotic lesions are permitted. Target vessel diameter between 2.5 mm and 3.75 mm and able to be treated with the available device size matrix. Each target lesion is treatable by a maximum of 3 scaffolds, and all target lesions(s) combined must be treatable by a maximum of 4 scaffolds. Total scaffold length among all target lesions must not exceed 120 mm (total sirolimus drug dose of 720 µg). Target lesion(s) must be at least 4 cm above the ankle joint Target lesion(s) are located in an area that may be stented without blocking access to patent main branches. A patent inflow artery from the aorta to the target lesion free from significant stenosis (≥50% diameter stenosis by visual estimate) must be present, as confirmed by angiography. Significant lesions (≥50% diameter stenosis) in inflow arteries must be treated successfully (per physician's assessment) using standard of care treatment prior to enrollment; inflow lesion treatment may be performed during the index procedure. Target vessel(s) reconstitute(s) at or above the ankle or displays normal terminal branching with inline flow to at least one patent (<50% diameter stenosis by visual assessment) outflow vessel. Exclusion Criteria: Clinical Exclusion Criteria Subjects will be excluded if any of the following criteria apply: Subject has severe medical comorbidities or other medical, social or psychological condition that could limit subject's ability to participate in the study or is associated with a life expectancy of less than 1 year. Subject has documented history of stroke within 3 months prior to the procedure. Subject has history of MI, within 30 days prior to the planned index procedure. Subjects with renal failure (estimated Glomerular Filtration Rate [eGFR] < 30 ml/min). Subject has non-atherosclerotic disease resulting in occlusion (e.g., embolism, Buerger's disease, vasculitis). Subject presents with CLI classified as Rutherford category 6. Subject has acute limb ischemia, defined as symptom onset occurring less than 14 days prior to the index procedure with associated loss of sensation or motor function. Subject had a major amputation that occurred less than one year prior to enrollment and subject is not independently ambulating. Subject has a planned major amputation (of either leg). Subject has had, or currently requires, surgical revascularization in the target vessel. Subject has a planned use of adjunctive primary treatment modalities (e.g., radiation therapy, stents) in below-the-knee vessels; plaque modification technology such as the use of atherectomy, laser or cutting balloons is permitted. Subject has any systemic infection or immunocompromised state. Subject has a coagulation disorder, including hypercoagulability; or the subject has contraindication to anticoagulant or antiplatelet therapy. Subject has a known history of heparin-induced thrombocytopenia (HIT) type II. Subject has known allergy or sensitivity to scaffold or scaffold components. Subject has a known allergy or sensitivity to contrast media that cannot be adequately pre-treated. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. Subject is currently participating in another investigational drug or device clinical study that has not yet met its primary endpoint. Angiographic Exclusion Criteria Subjects will be excluded if any of the following criteria apply: Target lesion(s) with severe calcification (PARC defined). Target lesion(s) will be subjected to significant bending and axial compression. Target lesion(s) located in highly tortuous vessels. Target lesion(s) previously stented (in-stent restenotic lesion). Target vessel(s) has any other significant lesions (≥50% diameter stenosis by visual assessment) that is not a target lesion. Target vessel previously treated within 3 months prior to index procedure Angiographic evidence of thromboembolism in target limb Inflow-limiting arterial stenoses are unsuccessfully treated or left untreated
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Gram
Phone
+1 (858) 966-3021
Email
dgram@revamedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jeff Anderson
Phone
+1 (858) 966-3038
Email
janderson@revamedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehrin Armstrong, MD
Organizational Affiliation
Adventist Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrej Schmidt, PD Dr.
Organizational Affiliation
University Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adventist Health
City
Saint Helena
State/Province
California
ZIP/Postal Code
94574
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ehrin Armstrong
First Name & Middle Initial & Last Name & Degree
Ehrin Armstrong, MD
Facility Name
University Leipzig
City
Leipzig
ZIP/Postal Code
04109
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrej Schmidt, MD

12. IPD Sharing Statement

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MOTIV BTK Randomized Controlled Trial

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