Trial reportEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2021
Super high-pressure balloon versus scoring balloon to prepare severely calcified coronary lesions: the ISAR-CALC randomised trial.
Trial report in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07093788 (Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions), which is not on this map. Cited by 33 papers, 2 of them syntheses that pooled it.
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.
Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions: a Randomized Controlled Trial (Shape)
Who cites it
33 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Network meta-analysis of treatment strategies for calcified coronary lesions.Cardiovascular intervention and therapeutics · 2026Pooled it
- Modified balloons to prepare severely calcified coronary lesions before stent implantation: a systematic review and meta-analysis of randomized trials.Clinical research in cardiology : official journal of the German Cardiac Society · 2024Pooled it
- Rotational atherectomy combined with cutting balloon to optimise stent expansion in calcified lesions: the ROTA-CUT randomised trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024Trial
- 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
- Comparative Performance of Calcium-Modification Strategies for Coronary Lesions: A Network Meta-Analysis of Randomized Trials.Cardiovascular therapeutics · 2026Article
- Optimal Stent Expansion Indices for Predicting Outcomes in PCI of Calcified Coronary Lesions.Clinical research in cardiology : official journal of the German Cardiac Society · 2025Article
- Prediction of Percutaneous Coronary Intervention Success in Patients With Moderate to Severe Coronary Artery Calcification Using Machine Learning Based on Coronary Angiography: Prospective Cohort Study.Journal of medical Internet research · 2025Article
- Randomized study assessing the effectiveness and safety of a novel scoring balloon for percutaneous coronary intervention: the Wedge NC trial.Journal of thoracic disease · 2025Article
- Percutaneous coronary intervention for calcified and resistant lesions.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025Review
- Calcified Coronary Artery Disease: Pathology, Prevalence, Predictors and Impact on Outcomes.Interventional cardiology (London, England) · 2025Review
- Percutaneous Coronary Interventions for Calcified Lesions: A Systematic Review with Meta-analyses of Randomised Trials.Interventional cardiology (London, England) · 2025Review
- A Case Report on the Use of Rotational Atherectomy for the Effective Management of Calcified Lesions.Cureus · 2025Article
- Quantitative Coronary Angiography Guidance for Drug-Eluting Stent Implantation: A Narrative Review.Health science reports · 2024Article
- Coronary Artery Calcium and Aging: Physiological Basis, Assessment, and Treatment Options in Percutaneous Coronary Intervention.Journal of cardiovascular development and disease · 2024Review
- Impact of coronary calcium morphology on intravascular lithotripsy.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024Article
- Coronary artery calcification: concepts and clinical applications.Annals of medicine and surgery (2012) · 2024Review
- Neoatherosclerosis: A Distinctive Pathological Mechanism of Stent Failure.Reviews in cardiovascular medicine · 2024Review
- Coronary calcifications, the Achilles heel in coronary interventions.Postepy w kardiologii interwencyjnej = Advances in interventional cardiology · 2024Review
- Dedicated Balloon Techniques for Coronary Calcium Modification.Interventional cardiology (London, England) · 2024Review
Corrections and comments
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe comparative efficacy of balloon-based techniques to prepare severely calcified coronary lesions before stenting remains poorly studied.
aimsWe sought to compare stent expansion following preparation of severely calcified coronary lesions with either a super high-pressure balloon or a scoring balloon.
methodsIn this randomised, open-label trial, patients with severely calcified coronary lesions were enrolled at five centres in Germany and Switzerland. After unsuccessful lesion preparation with a standard non-compliant balloon (<30% reduction of baseline diameter stenosis), participants were randomised to predilation with either a super high-pressure balloon or a scoring balloon before drug-eluting stent (DES) implantation. The primary endpoint of the study was stent expansion index as assessed by optical coherence tomography (OCT). The key secondary endpoints included angiographic, strategy and procedural success.
resultsOCT data after DES implantation were available for 70 out of 74 patients (94.6%) enrolled. Lesion preparation with a super high-pressure balloon versus a scoring balloon led to a comparable stent expansion index (0.72±0.12 vs 0.68±0.13; p=0.22). Compared with the scoring balloon, the super high-pressure balloon increased the minimum lumen diameter (2.83±0.34 mm vs 2.65±0.36 mm; p=0.03) and reduced the diameter stenosis (11.6±4.8% vs 14.4±5.6%; p=0.02) without difference in terms of angiographic success (100% vs 97.3%; p>0.99). Strategy success (91.9% vs 83.8%; p=0.48) and procedural success (100% vs 89.2%; p=0.12) were numerically more frequent with the super high-pressure balloon versus the scoring balloon.
conclusionsIn patients with severely calcified coronary artery lesions, preparation with a super high-pressure balloon versus a scoring balloon was associated with comparable stent expansion on intravascular imaging and a trend towards improved angiographic performance. Visual summary. A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions: the ISAR-CALC randomised trial.
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