Trial reportVascular medicine (London, England)2023
Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries.
Trial report in Vascular medicine (London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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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.
The trial behind it
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 29 citations in OpenAlex.
- Endovascular Treatment Modalities for Infrapopliteal Artery Disease: A Bayesian Network Meta-Analysis with Exploratory Evaluation of Retrievable Scaffold Therapy.Cardiovascular and interventional radiology · 2026Review
- Five-year histological evaluation of paclitaxel-eluting stent for an infrapopliteal lesion: a case report.European heart journal. Case reports · 2026Article
- Article
- Catch Up with the Latest Trend in Vascular Intervention-Chronic Limb-threatening Ischemia Up to Date.Interventional radiology (Higashimatsuyama-shi (Japan) · 2025Review
- Algorithm for the Revascularization of Infrainguinal Arterial Disease.Vascular specialist international · 2025Review
- [AVK III: Below the knee].Innere Medizin (Heidelberg, Germany) · 2025Review
- Drug-eluting devices for lower limb peripheral arterial disease.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024Review
- Maglev-fabricated long and biodegradable stent for interventional treatment of peripheral vessels.Nature communications · 2024Article
- Current Status of and Future Prospects for Drug-Eluting Stents and Scaffolds in Infrapopliteal Arteries.Journal of clinical medicine · 2024Review
- Surgical and Endovascular Therapies for Below-the-Knee Peripheral Arterial Disease: A Contemporary Review.Journal of the Society for Cardiovascular Angiography & Interventions · 2024Review
Corrections and comments
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Authors and funding
19 authors at 15 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEffective and durable options for infrapopliteal artery revascularization for patients with chronic limb-threatening ischemia (CLTI) are limited.
methodsThe SAVAL trial is a prospective, multicenter, randomized trial of patients with CLTI and infrapopliteal artery lesions with total lesion length ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary effectiveness endpoint was primary vessel patency (i.e., core lab-adjudicated duplex ultrasound-based flow at 12 months in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion). The primary safety endpoint was the 12-month major adverse event (MAE)-free rate; MAEs were defined as a composite of above-ankle index limb amputation, major reintervention, and 30-day mortality. The endpoints were prespecified for superiority (effectiveness) and noninferiority (safety) at a one-sided significance level of 2.5%.
resultsA total of 201 patients were enrolled and randomly assigned to treatment (
conclusionThe SAVAL trial did not show benefit related to effectiveness and safety with the nitinol DES compared with PTA in infrapopliteal artery lesions up to 140 mm in length. Continued innovation to provide optimal treatments for CLTI is needed.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.