ArticleJournal of thoracic disease2025
Randomized study assessing the effectiveness and safety of a novel scoring balloon for percutaneous coronary intervention: the Wedge NC trial.
Article in Journal of thoracic disease, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06214247 (A Prospective, Open Label, Multi-center, Randomized Study Designed to Evaluate the Safety and Efficacy of Scoring PTCA Catheter on Subjects During Percutaneous Coronary Intervention), which is not on this map. Cited by 2 papers.
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.
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.
A Prospective, Open Label, Multi-center, Randomized Study Designed to Evaluate the Safety and Efficacy of Scoring PTCA Catheter on Subjects During Percutaneous Coronary Intervention
Who cites it
2 citing papers in PubMed.
- Novel Hertz Contact Intravascular Lithotripsy: Could We Achieve More in Balloon-Based Calcium Modification?Journal of clinical medicine · 2026Review
- Calcium modifying dedicated balloons: a contemporary review.Frontiers in cardiovascular medicine · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Scoring balloon angioplasty catheters are designed to induce high focal stress at low inflation pressure for better lesion modification. We aimed to assess the effectiveness and safety of a newly developed Wedge NC scoring balloon catheter compared to the ScoreFlex coronary dilatation catheter for treating coronary artery lesions. Methods: The Wedge NC trial was a prospective, multicenter, open-label, randomized controlled non-inferiority trial conducted during August 2021 and February 2022. There were 198 patients with indication for percutaneous coronary intervention (PCI) enrolled at nine centers in China. Patients undergoing angioplasty were randomly assigned to treatment with the Wedge NC scoring balloon or the ScoreFlex scoring balloon. The primary endpoint was procedure success, defined as the residual stenosis of the target lesion ≤30% immediately after PCI procedure, without complications (limited to death, Q-wave or non-Q-wave myocardial infarction, or emergent coronary artery bypass grafting during postoperative hospitalization). The secondary endpoints included rate of clinical success, device procedural success, balloon slippage, and angiographic traits measured by quantitative coronary analysis. Results: Baseline parameters showed no differences between the two groups. Procedure success was achieved in 98 of 99 patients in both groups. The mean difference between the Wedge group and the ScoreFlex group was 0 (95% confidence interval: -2.79% to 2.79%, 1-sided P<0.001 with both Wald method and minimum risk weights method). Noninferiority at a predefined margin of 7% was established. Immediately after the balloon inflation, minimal lumen diameter in the Wedge group was significantly larger than that of the ScoreFlex group (1.71±0.39 Conclusions: In patients undergoing PCI, the Wedge NC scoring balloon dilatation catheter was noninferior to the ScoreFlex coronary dilatation catheter regarding procedure success and had comparably low procedural complication rate. (Sponsored by BrosMed Medical.). Trial Registration: The trial was registered at clinicaltrials.gov with the identifier NCT06214247.
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Registered trials
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