ArticleCVIR endovascular2026
Sirolimus-eluting balloon for the treatment of peripheral artery disease: SUCCESS PTA real-world single-arm study.
Article in CVIR endovascular, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOutcomes with sirolimus-coated drug-eluting balloons (DEB) have been positive for the treatment of femoropopliteal arterial lesions but have not been studied in a broader patient population.
objectivesCollect real-world safety and effectiveness data on the SELUTION SLR DEB in patients with claudication and chronic limb-threatening ischemia (CLTI).
methodsThis international multi-center, prospective, single-arm, post-market study (SUCCESS PTA) enrolled 723 patients at 27 sites. The primary endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) after 1 year.
resultsMedian age was 71.0 [63.0-79.0] years, 65% were male, 25.7% had CLTI. In total, 822 lesions were included; median lesion length was 100.0 mm [50.0-190.0] with 42.1% chronic total occlusions and 36.4% moderate-to-severe calcification. At 12 months, freedom from CD-TLR was 91.1%, 95% CI [88.6-93.1] and 52.1% of patients were asymptomatic. Median EQ-VAS score and ankle-brachial pressure index improved significantly from baseline to 12 months (65.0 [50.0-80.0] vs. 75.0 [60.0-85.0] (p < 0.0001)) and (0.6 [0.5-0.8] vs. 0.9 [0.8-1.0] (p < 0.0001)), respectively. At 12 months, outcomes in CLTI patients included major target limb amputation, 5.8%; major cardiac event rate, 4.3%; and death, 11.3%. Respective outcomes for those with claudication were 0.0%, 2.2% and 1.2%.
conclusionsThis real-world single-arm study is the largest assessment of a sirolimus DEB for treatment in claudication and CLTI. The outcomes were consistent with those reported for paclitaxel-coated balloons and support this DEB platform as a promising alternative, particularly in CLTI patients. LEVEL OF EVIDENCE: Level 3.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.