Tom 13, Nr 6 (2018)
Krótkie doniesienie naukowe
Opublikowany online: 2019-02-04

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Eksport do Mediów Społecznościowych

Eksport do Mediów Społecznościowych

Short-term results of the First-in-Man new Non-Complaint Balloon Catheter clinical study

Jacek Bil1, Tomasz Pawłowski1, Robert J. Gil1
Kardiol Inwazyjna 2018;13(6):4-9.


Background: Nowadays, non-complaint balloon catheters are used to predilate heavily calcified lesions before stenting, to postdilate the implanted stent to optimize its parameters, to finalize bifurcation treatment in final kissing balloon technique as well as to treat restenosis, especially in implanted earlier stents. The aim of this paper was to verify clinical effectiveness and safety profile of the new non-complaint balloon catheter (Balton, Poland). Methods: It was a first-in-man analysis of the use of Balton NC balloon angioplasty catheter in patients undergoing percutaneous coronary interventions. There were included consecutive patients with age ≥ 18 years old, with coronary artery disease undergoing percutaneous coronary interventions in lesion requiring predilatation or postdilatation and who signed the informed consent. The local IRB approved the study protocol (No 135/2017). The primary endpoint was to compare balloon diameters obtained in QCA to diameters declared by the producer reached at certain pressures. Results: A total of 21 patients were enrolled. In most cases patients presented with the multivessel disease (61.9%) and lesions of the moderate complexity (type B1 – 71.4%, type B2 – 4.8%). Lesions were located most frequently in the left circumflex artery (47.6%, n = 10). The device success rate was 100%. All procedures were performed via the 6F guiding catheter (100%) and in 95.2% (n = 20/21) - the radial access was preferred. There were no significant differences between QCA and expected balloon diameters when applied the nominal pressure both in predilatation (2.32±0.31 mm vs 2.38 ± 0.43 mm,  2.5%) as well as in postdilatation (2.90±0.38 mm vs 2.96 ± 0.47 mm,  2.0%). There were only two dissection cases (1 type A and 1 type B). Conclusions: The presented data confirm the effectiveness and safety profile of Balton NC balloon catheters. There the device success rate was 100%, and there were no severe complications. In QCA analysis Balton NC balloon catheters reached assumed diameters and lengths at given pressures.

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