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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

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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… Click to show full abstract

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 (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 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.

Keywords: low profile; balloon; conventional balloon; group; blimp

Journal Title: Acta Cardiologica
Year Published: 2022

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