ArticleCardiovascular and interventional radiology2025
MOTIV Bioresorbable Scaffold in Below-The-Knee Artery Disease: European Post-Market Pilot BTK Trial: 36-Month Results.
Article in Cardiovascular and interventional radiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Additive Manufacturing of Polymeric Bioresorbable Stents: A Mechanical Performance Perspective.Biomaterials research · 2026Review
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTHE primary objective of the MOTIV BTK PILOT STUDY WAs to evaluate the immediate and long-term safety and efficacy of the MOTIV® sirolimus-eluting bioresorbable scaffold (Reva Medical, San Diego, California, USA) in below-the-knee (BTK) arteries for the treatment of patients with rest pain or minor tissue loss (critical limb-threatening ischemia (CLTI)). MATERIALS AND
methodsThis is a prospective, single-arm, multi-center trial of a novel drug-eluting bioresorbable scaffold with a new scaffold material (Tyrocore®), which includes an iodinated, polycarbonate copolymer of tyrosine analogs and has a surface coating of the same Tyrocore material and the antiproliferative drug sirolimus. Fifty-eight patients were included between August 2019 and July 2021. The primary efficacy outcome measure was primary patency at 12 months. The primary safety outcome measure was freedom from serious device-related adverse events at 30 days. Secondary outcome measures were immediate technical success, primary patency at 24 and 36 months, clinically driven target lesion revascularization rate (CD-TLR) and limb salvage at 12, 24, and 36 months. Follow-up was performed at 1, 6, 24, and 36 months, including clinical assessment and core laboratory adjudicated color duplex ultrasound.
resultsSeventy-six MOTIV scaffolds were implanted in 60 study limbs with an average lesion length of 29.5 mm. Primary patency at 12, 24, and 36 months was 88.3%, 81.7%, and 80% (with numbers of limbs at risk being 43, 38 & 30) respectively. The 30-day adverse event rate was 1.7%. Technical success was achieved in 99%. At 3 years, freedom from CD-TLR was 93% and limb salvage rate was 95%.
conclusionThe 36-month results of this pilot MOTIV BTK study demonstrated favorable safety and effectiveness performance in CLTI patients with BTK atherosclerotic disease. LEVEL OF EVIDENCE: Level 3: non-randomized controlled cohort study.
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