ArticleJACC. Asia2026
Safety and Efficacy of a Novel Rotational Atherectomy System in Coronary Calcifications: The CORECT Trial.
Article in JACC. Asia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05447585 (A Prospective, Multicenter Clinical Trial of Coronary Atherectomy System in Patients With Calcified Coronary Artery Lesion), which is not on this map. Cited by 1 paper.
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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
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A Prospective, Multicenter Clinical Trial of Coronary Atherectomy System in Patients With Calcified Coronary Artery Lesion
Who cites it
1 citing paper in PubMed.
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Corrections and comments
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Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCalcified coronary lesions present challenges during percutaneous coronary intervention, often impeding successful stent delivery and expansion. Rotational atherectomy (RA) facilitates plaque modification in such cases. However, clinical performance of a novel RA system remains unclear.
objectivesThis noninferiority study evaluated the safety and efficacy of the novel system.
methodsThis trial included 2 prospective phases, a first-in-human (FIH) study and a pivotal randomized controlled trial. In the FIH study, 15 patients underwent percutaneous coronary intervention with the novel RA system, and clinical success was assessed. In pivotal trial, 224 patients with calcified lesions were randomized to receive RA using either the novel (n = 111) or established (n = 113) system, followed by stenting. The primary endpoint was freedom from major adverse cardiovascular events (MACEs), a composite of cardiac death, myocardial infarction, and target vessel revascularization, at 30 days. Secondary endpoints included MACEs at 12 months and quantitative imaging analyses.
resultsAll FIH patients achieved clinical success. In pivotal study, the median follow-up time was 349.5 (IQR: 343, 359) days. Freedom from MACEs at 30 days was 97.3% (108 of 111 vs 110 of 113; 95% CI: 92.3%-99.4% vs 92.4%-99.5%) in both groups (P for noninferiority <0.0001). At 12 months, MACEs remained low in both groups (2.7%; 95% CI: 0.9%-8.1% vs 2.7%; 95% CI: 0.9%-8.0%; P = 1.0000). Postprocedural minimal stent area was similar on intravascular ultrasound between the 2 groups (5.29 ± 1.20 vs 5.29 ± 1.47 mm
conclusionsThe novel RA system demonstrated noninferior safety and efficacy to established system, offering an effective alternative for the treatment of complex calcified coronary lesions. (CorOnary atheRectomy system in patiEnts with Coronary arTery calcification (CORECT); NCT05447585).
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