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CardioVascular and Interventional Radiology

Published in:

01-04-2019 | Clinical Investigation

Phase II Trial of Transarterial Embolization Using an n-Butyl-2-Cyanoacrylate/Lipiodol Mixture (JIVROSG-0802)

Authors: Shunsuke Sugawara, Yasuaki Arai, Miyuki Sone, Tsuneo Ishiguchi, Akira Kitagawa, Takeshi Aramaki, Rui Sato, Hiroyuki Morishita, Yoshito Takeuchi, Yoshitaka Inaba

Published in: CardioVascular and Interventional Radiology | Issue 4/2019

Abstract

Purpose

To evaluate the embolic effect and the safety of transarterial embolization (TAE) using n-butyl-2-cyanoacrylate (NBCA) in a prospective multicenter trial.

Materials and Methods

This study was an open-label, multicenter, phase II trial. The inclusion criteria were (1) active bleeding or pseudoaneurysm, (2) true aneurysm, (3) arteriovenous malformation (except cerebral lesion), (4) arteriovenous fistula, or (5) need for arterial distribution before transarterial treatment. Selective TAE with NBCA diluted 2–10 times was performed. The primary endpoint was the success rate of embolization with a per-patient analysis based on the angiographic findings. Secondary endpoints were safety, evaluated based on Common Terminology Criteria for Adverse Events (CTCAE) version 4, and the success rate of embolization with a per-vessel calculation.

Results

Sixty-five patients were initially enrolled, but due to protocol violation in two patients, efficacy was ultimately analyzed in 63 patients (103 vessels) and safety was analyzed in 64 patients. The success rate per patient was 98.4% (62/63; 95% confidence interval (CI), 91.5–100.00), and the success rate per vessel was 99.0% (102/103; 95% CI, 94.7–100.0). Adverse events of grade 3 or above based on CTCAE version 4 occurred in 22/64 patients (34.4%). Twelve intraoperative or postoperative adverse events grade 3 or above, which may have been related to embolization using NBCA, occurred in 11/64 patients (17.2%). Three patients died after embolization using NBCA, but their deaths were unrelated to TAE.

Conclusion

In this prospective multicenter clinical trial, the efficacy of TAE using NBCA was 98.4% and adverse events were clinically acceptable.

Level of Evidence

Level 3b.

Available only for authorised users

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Title: Phase II Trial of Transarterial Embolization Using an n-Butyl-2-Cyanoacrylate/Lipiodol Mixture (JIVROSG-0802)
Authors: Shunsuke Sugawara
Yasuaki Arai
Miyuki Sone
Tsuneo Ishiguchi
Akira Kitagawa
Takeshi Aramaki
Rui Sato
Hiroyuki Morishita
Yoshito Takeuchi
Yoshitaka Inaba
Publication date: 01-04-2019
Publisher: Springer US
Published in: CardioVascular and Interventional Radiology / Issue 4/2019
Print ISSN: 0174-1551
Electronic ISSN: 1432-086X
DOI: https://doi.org/10.1007/s00270-018-2141-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Phase II Trial of Transarterial Embolization Using an n-Butyl-2-Cyanoacrylate/Lipiodol Mixture (JIVROSG-0802)

Abstract

Purpose

Materials and Methods

Results

Conclusion

Level of Evidence

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Materials and Methods

Results

Conclusion

Level of Evidence

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