Evaluation of a new bioresorbable scaffold for treating critical limb ischemia

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

This study is testing a new type of dissolvable scaffold to see if it can help improve blood flow and relieve symptoms in people with critical limb ischemia when used with a special balloon treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 292 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: REVA Medical, Inc. (industry)
• Drugs / interventions: radiation
• Locations: 4 sites (St. Helena, California and 3 other locations)
• Trial ID: NCT05406622 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for treating infrapopliteal lesions in patients with critical limb ischemia (CLI). Participants will undergo treatment with this innovative scaffold in conjunction with a percutaneous transluminal angioplasty (PTA) device. The study aims to assess the safety and effectiveness of this new approach in improving blood flow and alleviating symptoms associated with CLI. Eligible patients will be monitored for compliance with protocol procedures and follow-up assessments.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with symptomatic critical limb ischemia classified as Rutherford category 4 or 5.

Not a fit: Patients with less severe forms of limb ischemia or those who do not meet the angiographic inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve blood flow and reduce symptoms for patients suffering from critical limb ischemia.

How similar studies have performed: While this approach is innovative, similar studies involving bioresorbable scaffolds have shown promise in other vascular conditions, suggesting potential for success.

Eligibility criteria

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

Where this trial is running

St. Helena, California and 3 other locations

• Adventist Health — St. Helena, California, United States (RECRUITING)
• UnityPoint Health Trinity Bettendorf Hospital — Bettendorf, Iowa, United States (RECRUITING)
• Cardiovascular Medicine PC — Davenport, Iowa, United States (RECRUITING)
• University Leipzig — Leipzig, Germany (RECRUITING)

Study contacts

• Principal investigator: Ehrin Armstrong, MD — Adventist Health
• Study coordinator: Danielle Gram

Conditions: Critical Limb Ischemia