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.
Acta Cardiol
; 78(1): 86-90, 2023 Feb.
Article
in En
| MEDLINE
| ID: mdl-35972446
ABSTRACT
BACKGROUND:
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:
We conducted a multicenter, prospective, randomised, controlled trial in which 126 patients with an uncrossable lesion were randomly (11 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:
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%; p = 0.761). Using a low-profile balloon in the BLIMP group after failure of the Blimp balloon increased the success to 64% (39 out of 61 cases). Using the Blimp balloon in the low-profile first group after failure of the low-profile balloon increased the success to 60% (40 out of 67 cases). After the placement of a guide catheter extension, the overall successful lesion crossing in the BLIMP group was 80% (49 out of 61 cases) compared to 76% (51 out of 67 cases) in the LP Balloon group (p = 0.327).CONCLUSIONS:
The Blimp balloon catheter showed no superiority to customary low-profile balloons in uncrossable lesions. It can however be complementary in treating uncrossable lesions.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Angioplasty, Balloon, Coronary
/
Coronary Occlusion
Type of study:
Clinical_trials
Limits:
Humans
Language:
En
Journal:
Acta Cardiol
Year:
2023
Document type:
Article
Affiliation country: