Actively Recruiting
MOTIV BTK Randomized Controlled Trial
Led by REVA Medical, Inc. · Updated on 2025-04-02
292
Participants Needed
4
Research Sites
355 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.
CONDITIONS
Official Title
MOTIV BTK Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Symptomatic critical limb ischemia classified as Rutherford category 4 or 5
- Willing to comply with all study procedures and follow-up assessments
- Signed informed consent form approved by IRB/EC
- Significant stenosis (>70% diameter) of one or two native infrapopliteal lesions in the same limb
- Target vessel diameter between 2.5 mm and 3.75 mm treatable with study devices
- Each lesion treatable with up to 3 scaffolds; total scaffolds not exceeding 4
- Total scaffold length must not exceed 120 mm (720 µg sirolimus dose)
- Lesions located at least 4 cm above the ankle joint
- Lesions treatable without blocking access to main branches
- Patent inflow artery from aorta to lesion with less than 50% stenosis
- Significant inflow artery lesions (>50% stenosis) treated successfully before or during procedure
- Target vessels reconstitute at or above the ankle with at least one patent outflow vessel
You will not qualify if you...
- Severe medical conditions or life expectancy less than 1 year
- Stroke within 3 months prior to procedure
- Heart attack within 30 days before procedure
- Renal failure with eGFR less than 30 ml/min
- Non-atherosclerotic disease causing occlusion (e.g., embolism, Buerger's disease, vasculitis)
- Critical limb ischemia classified as Rutherford category 6
- Acute limb ischemia with symptom onset less than 14 days ago with loss of sensation or motor function
- Major amputation less than one year ago without independent ambulation
- Planned major amputation of either leg
- Previous or planned surgical revascularization in target vessel
- Planned use of adjunctive primary treatments like radiation or stents below the knee
- Systemic infection or immunocompromised state
- Coagulation disorders or contraindication to anticoagulant/antiplatelet therapy
- History of heparin-induced thrombocytopenia type II
- Known allergy to scaffold components or contrast media not adequately pre-treated
- Pregnancy, nursing, or planning pregnancy during study
- Participation in another investigational drug or device study not completed
- Target lesions with severe calcification or in highly tortuous vessels
- Target lesions previously stented or treated within 3 months
- Untreated or unsuccessfully treated inflow-limiting arterial stenoses
- Angiographic evidence of thromboembolism in target limb
- Target lesions subjected to significant bending or axial compression
- Target vessel has other significant lesions not targeted in study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Adventist Health
St. Helena, California, United States, 94574
Actively Recruiting
2
UnityPoint Health Trinity Bettendorf Hospital
Bettendorf, Iowa, United States, 52722
Actively Recruiting
3
Cardiovascular Medicine PC
Davenport, Iowa, United States, 52803
Actively Recruiting
4
University Leipzig
Leipzig, Germany, 04109
Actively Recruiting
Research Team
D
Danielle Gram
CONTACT
J
Jeff Anderson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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