A prospective, multi-center, randomised controlled trial for evaluation of the effectiveness of the Blimp scoring balloon in lesions not crossable with a conventional balloon or microcatheter: the BLIMP study.


Journal

Acta cardiologica
ISSN: 1784-973X
Titre abrégé: Acta Cardiol
Pays: England
ID NLM: 0370570

Informations de publication

Date de publication:
Feb 2023
Historique:
pubmed: 17 8 2022
medline: 22 2 2023
entrez: 16 8 2022
Statut: ppublish

Résumé

Balloon uncrossable coronary lesions are lesions that cannot be crossed with a conventional balloon. Multiple balloons have been designed to overcome this problem. The Blimp balloon has a very low scoring profile (0.6 mm) with a very high rated burst pressure (30 atmospheres). We aimed to evaluate the efficacy of this balloon compared to customary low-profile balloons. We conducted a multicenter, prospective, randomised, controlled trial in which 126 patients with an uncrossable lesion were randomly (1:1 randomization) assigned to treatment first with the Blimp balloon or low-profile balloon. The primary endpoint was the success of crossing the lesion after initial failure with a microcatheter (group A) or with a conventional balloon (group B). Overall, the first attempt of Blimp was successful in 29 out of 61 cases (48%) while the LP balloon immediately crossed in 30 out 67 cases (45%; The Blimp balloon catheter showed no superiority to customary low-profile balloons in uncrossable lesions. It can however be complementary in treating uncrossable lesions.

Sections du résumé

BACKGROUND UNASSIGNED
Balloon uncrossable coronary lesions are lesions that cannot be crossed with a conventional balloon. Multiple balloons have been designed to overcome this problem. The Blimp balloon has a very low scoring profile (0.6 mm) with a very high rated burst pressure (30 atmospheres). We aimed to evaluate the efficacy of this balloon compared to customary low-profile balloons.
METHODS UNASSIGNED
We conducted a multicenter, prospective, randomised, controlled trial in which 126 patients with an uncrossable lesion were randomly (1:1 randomization) assigned to treatment first with the Blimp balloon or low-profile balloon. The primary endpoint was the success of crossing the lesion after initial failure with a microcatheter (group A) or with a conventional balloon (group B).
RESULTS UNASSIGNED
Overall, the first attempt of Blimp was successful in 29 out of 61 cases (48%) while the LP balloon immediately crossed in 30 out 67 cases (45%;
CONCLUSIONS UNASSIGNED
The Blimp balloon catheter showed no superiority to customary low-profile balloons in uncrossable lesions. It can however be complementary in treating uncrossable lesions.

Identifiants

pubmed: 35972446
doi: 10.1080/00015385.2022.2058676
doi:

Types de publication

Randomized Controlled Trial Multicenter Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

86-90

Auteurs

J Dens (J)

Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.

W Holvoet (W)

Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.

K McCutcheon (K)

Department of Cardiology, Universitair Ziekenhuis Leuven Gasthuisberg, Leuven, Belgium.

C Ungureanu (C)

Department of Cardiology, Hôpital de Jolimont, La Louvière, Belgium.

P Coussement (P)

Department of Cardiology, AZ Sint-Jan, Brugge, Belgium.

S Haine (S)

Department of Cardiology, Universitair Ziekenhuis Antwerpen, Edegem, Belgium.

Q De Hemptinne (Q)

Department of Cardiology, Universitair Medisch Centrum, Bruxelles, Belgium.

J Sonck (J)

Department of Cardiology, Onze-Lieve-vrouwziekenhuis Aalst, Aalst, Belgium.

W Eertmans (W)

Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.

J Bennett (J)

Department of Cardiology, Universitair Ziekenhuis Leuven Gasthuisberg, Leuven, Belgium.

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Classifications MeSH