Feasibility and Safety of the New Coronary Noncompliant Balloon Catheter River NC^®

Abstract

Aim: In this preliminary study, we aimed to confirm the clinical utility and safety of the new noncompliant balloon catheter River NC^® (Balton, Poland). Materials & methods: The primary study end point was to verify balloon diameters calculated in quantitative coronary angiography (QCA) to diameters prespecified by the manufacturer and obtained at given pressures in subjects undergoing percutaneous coronary interventions. Results: Forty-two subjects were enrolled (73.8% multivessel disease; 40.5% type B1 lesions; 100% device success). No clinically significant differences between expected balloon diameters and QCA were registered in predilatation (2.36 ± 0.11 mm vs 2.43 ± 0.07 mm) and postdilatation (3.18 ± 0.19 mm vs 3.21 ± 0.31 mm). Conclusion: Our study results suggest that the River NC balloon is effective and safe. In the QCA evaluation, River NC balloon obtained prespecified diameters and lengths at applied pressures.

Study registration: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (UR.D.WM.DNB.109.2019).

Lay abstract

In this study, we aimed to assess the utility and safety aspects of River NC^® (Balton, Poland), a new type of catheter with thicker walls, which is used to stretch open a narrowed or blocked artery, the main blood vessels supplying the heart. Forty-two patients were included. Our study results suggested that the River NC balloon was effective and safe because it achieved the expected diameters and length when inserted into the patients.

Keywords:

• balloon angioplasty
• coronary artery disease
• PCI
• procedure optimization

Author contributions

All authors equally contributed to this work and take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.

Financial & competing interests disclosure

RJ Gil is a consultant of Balton Company (manufacturer of the River NC balloon catheters). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, informed consent has been obtained from the participants involved.

Data sharing statement

The authors certify that this manuscript reports original clinical trial data. The data will not be made publicly available.