MOTIV BTK Randomized Controlled Trial

NCT05406622 | Recruiting DMC FDA Device

• 1 other identifier: HCT6800
• Study Type: interventional
• Target: 292
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (2)

• 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).

  6 Months

• 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.

  30 Days

Study Arms (2)

MOTIV Sirolimus-Eluting Bioresorbable Scaffold

EXPERIMENTAL

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

Device: MOTIV Sirolimus-Eluting Bioresorbable Scaffold

Percutaneous Transluminal Angioplasty (PTA)

ACTIVE COMPARATOR

Participants who receive PTA treatment will be included in this arm

Device: Percutaneous Transluminal Angioplasty (PTA) Device

Interventions

MOTIV Sirolimus-Eluting Bioresorbable Scaffold DEVICE

Participants will receive the MOTIV device

MOTIV Sirolimus-Eluting Bioresorbable Scaffold

Percutaneous Transluminal Angioplasty (PTA) Device DEVICE

Participants will receive PTA treatment

Percutaneous Transluminal Angioplasty (PTA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• REVA Medical, Inc.: lead

Study Sites (4)

Adventist Health

St. Helena, California, 94574, United States

RECRUITING

UnityPoint Health Trinity Bettendorf Hospital

Bettendorf, Iowa, 52722, United States

RECRUITING

Cardiovascular Medicine PC

Davenport, Iowa, 52803, United States

RECRUITING

University Leipzig

Leipzig, 04109, Germany

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Ehrin Armstrong, MD

  Adventist Health

  PRINCIPAL INVESTIGATOR

• Andrej Schmidt, PD Dr.

  University Leipzig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Gram

CONTACT

+1 (858) 966-3021; dgram@revamedical.com

Jeff Anderson

CONTACT

+1 (858) 966-3038; janderson@revamedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 6, 2022
• Study Start: June 10, 2022
• Primary Completion: September 30, 2025
• Study Completion (Estimated): March 31, 2029
• Last Updated: April 2, 2025

Record last verified: 2025-04

Locations

US (3); DE (1)