ArticlePloS one2025
Equivalence and endothelial safety of temporary intracoronary shunt device: Insights from preclinical porcine and rabbit models.
Article in PloS one, 2025. 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
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis preclinical investigation evaluated the operational equivalence of a temporary intracoronary shunt (TICS) device while documenting patterns of endothelial repair during the perioperative period.
methodsPorcine coronary bypass models were established using off-pump (OPCAB) and on-pump beating-heart surgical approaches. Through a triple randomization design, test devices and predicate counterparts were deployed in left/right coronary arteries. Equivalence was determined at postoperative day 7 through tripartite analysis: 1) sequential laboratory measurements (preoperative to 7-day follow-up), 2) histopathological evaluation of vascular specimens, and 3) angiographic assessment. Extreme-sized device validation employed rabbit carotid arteries (small-caliber vascular bed) and abdominal aortae (large-caliber model), with equivalence criteria encompassing hemodynamic stability (flow velocity, trans-device pressure differentials) and microarchitectural preservation (endothelial integrity, internal elastic lamina continuity).
resultsIn the conventional device cohort (12 target vessels), no perioperative type 5 myocardial infarction occurred. Postoperative CTA confirmed patent lumens and unobstructed distal flow in all vessels. Cardiac biomarkers (troponin, CK-MB, myoglobin) showed no significant differences at preoperative, 4h, 8h, 24h, 72h, or 7-day timepoints (P ≥ 0.05). For extreme-sized devices, hemodynamic parameters (mean proximal/distal pressure: test vs. predicate, P ≥ 0.05) and endothelial outcomes, including elastic lamina injury scores, demonstrated equivalence between test and predicate devices.
conclusionFunctional parity between TICS and predicate devices was established in both porcine and lagomorph models, with observed endothelial alterations demonstrating transient characteristics limited to the acute perioperative window.
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.