MOTIV BTK Randomized Controlled Trial

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

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

Study Overview

• Status: Recruiting
• Conditions: Critical Limb Ischemia
• Intervention / Treatment: Device: Percutaneous Transluminal Angioplasty (PTA) Device; Device: MOTIV Sirolimus-Eluting Bioresorbable Scaffold

• Study Type: Interventional
• Enrollment (Estimated): 292
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danielle Gram; Phone Number: +1 (858) 966-3021; Email: dgram@revamedical.com
• Study Contact Backup: Name: Jeff Anderson; Phone Number: +1 (858) 966-3038; Email: janderson@revamedical.com

Study Locations

• Germany
  • Leipzig, Germany, 04109
    • Recruiting
    • University Leipzig
    • Principal Investigator: Andrej Schmidt, MD
• United States
  • California
    • Saint Helena, California, United States, 94574
      • Recruiting
      • Adventist Health
      • Contact: Ehrin Armstrong
      • Principal Investigator: Ehrin Armstrong, MD
  • Iowa
    • Bettendorf, Iowa, United States, 52722
      • Recruiting
      • UnityPoint Health Trinity Bettendorf Hospital
      • Contact: Gail Shammas; Email: shammasg@mcrfmd.com
      • Principal Investigator: Nicolas Shammas, MD
      • Sub-Investigator: Amit Bahia, MD
    • Davenport, Iowa, United States, 52803
      • Recruiting
      • Cardiovascular Medicine PC
      • Contact: Gail Shammas; Email: shammasg@mcrfmd.com
      • Principal Investigator: Nicolas Shammas, MD
      • Sub-Investigator: Amit Bahia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MOTIV Sirolimus-Eluting Bioresorbable Scaffold; Participants who receive the MOTIV device will be included in this arm	Device: MOTIV Sirolimus-Eluting Bioresorbable Scaffold; Participants will receive the MOTIV device
Active Comparator: Percutaneous Transluminal Angioplasty (PTA); Participants who receive PTA treatment will be included in this arm	Device: Percutaneous Transluminal Angioplasty (PTA) Device; Participants will receive PTA treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: REVA Medical, Inc.
• Investigators: Principal Investigator: Ehrin Armstrong, MD, Adventist Health; Principal Investigator: Andrej Schmidt, PD Dr., University Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Atherosclerosis; Peripheral Vascular Diseases; Chronic Disease; Peripheral Arterial Disease; Ischemia; Chronic Limb-Threatening Ischemia; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: HCT6800

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes