Scoring balloon catheter with three nylon elements having a triangular cross section of height 0.39 mm, bonded distally and proximally of the balloon (left panel, courtesy Nipro Corporation, Japan). When the balloon is inflated, the three non-slip elements are positioned on the cylindrical surface of the balloon spaced with 120° from each other (right panel)
Calcified Lesion Modification Using Scoring Balloon
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Corresponding Organization :
Other organizations : Klinikum Ernst von Bergmann, National Heart Institute, B. Braun (Germany), Charité - Universitätsmedizin Berlin, Hospital Universitario Lucus Augusti, University of Malaya, Queen Elizabeth Hospital, Jüdisches Krankenhaus Berlin, St. Marien Hospital, Hospital Kuala Lumpur
Variable analysis
- Scoring balloon device used for lesion preparation
- Diameter of the balloon (2.00 to 4.00 mm)
- Calcified lesion modification as measured by optical coherence tomography
- Length of the scoring balloon device (13 mm)
- Type of drug-coated balloon (iopromide–paclitaxel-coated DCB)
- Positive control: Previous observational studies showing favorable rating of calcified lesion modification using the scoring balloon device [18]
- Negative control: No class effect for DCB devices mentioned [4]
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