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GREAT-a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results

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GREAT-a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results. / Taschner, Christian A; Chapot, René; Costalat, Vincent; Machi, Paolo; Courthéoux, Patrick; Barreau, Xavier; Berge, Jérôme; Pierot, Laurent; Kadziolka, Kryzsztof; Jean, Betty; Blanc, Raphaël; Biondi, Alessandra; Brunel, Hervé; Gallas, Sophie; Berlis, Ansgar; Herbreteau, Denis; Berkefeld, Joachim; Urbach, Horst; El Shikh, Samer; Fiehler, Jens; Desal, Hubert; Graf, Erika; Bonafé, Alain.

In: NEURORADIOLOGY, Vol. 58, No. 8, 08.2016, p. 777-86.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Taschner, CA, Chapot, R, Costalat, V, Machi, P, Courthéoux, P, Barreau, X, Berge, J, Pierot, L, Kadziolka, K, Jean, B, Blanc, R, Biondi, A, Brunel, H, Gallas, S, Berlis, A, Herbreteau, D, Berkefeld, J, Urbach, H, El Shikh, S, Fiehler, J, Desal, H, Graf, E & Bonafé, A 2016, 'GREAT-a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results', NEURORADIOLOGY, vol. 58, no. 8, pp. 777-86. https://doi.org/10.1007/s00234-016-1693-y

APA

Taschner, C. A., Chapot, R., Costalat, V., Machi, P., Courthéoux, P., Barreau, X., Berge, J., Pierot, L., Kadziolka, K., Jean, B., Blanc, R., Biondi, A., Brunel, H., Gallas, S., Berlis, A., Herbreteau, D., Berkefeld, J., Urbach, H., El Shikh, S., ... Bonafé, A. (2016). GREAT-a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results. NEURORADIOLOGY, 58(8), 777-86. https://doi.org/10.1007/s00234-016-1693-y

Vancouver

Taschner CA, Chapot R, Costalat V, Machi P, Courthéoux P, Barreau X et al. GREAT-a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results. NEURORADIOLOGY. 2016 Aug;58(8):777-86. https://doi.org/10.1007/s00234-016-1693-y

Bibtex

@article{e169cbe3fcc84428af51c2afa01ac79e,
title = "GREAT-a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results",
abstract = "INTRODUCTION: Hybrid hydrogel-platinum coils (HydroCoil) have proven effective for endovascular aneurysm treatment. To overcome technical limitations (coil stiffness, time restriction for placement), a second generation of softer hydrogel coils has been brought to clinical practice (HydroSoft, HydroFrame). We report on procedural safety and core-lab-assessed angiographic results from an open-label multicenter randomized controlled trial.METHODS: Web-based randomization occurred in 15 medical centers in France and seven in Germany between coil embolization with second-generation hydrogel coils and treatment with any bare platinum coil. Assist devices could be used as clinically required. Primary endpoint is a composite outcome including major aneurysm recurrence and poor clinical outcome at 18 months follow-up.RESULTS: Five hundred thirteen patients were randomized (hydrogel n = 256, bare platinum n = 257). Twenty patients were excluded for missing informed consent and nine patients for treatment related criteria. Four hundred eighty-four patients were analyzed as randomized (hydrogel n = 243, bare platinum n = 241). Two hundred eight had ruptured aneurysms (43 %). Prespecified procedural complications occurred in 58 subjects (hydrogel n = 28, bare platinum n = 30, p = 0.77). The 14-day mortality rate was 2.1 % in both arms of the study. The median calculated packing densities for aneurysms assigned to hydrogel and bare platinum were 39 and 31 % respectively (p < 0.001). No statistically significant differences were found between arms in the post procedural angiographic occlusion rate (p = 0.8).CONCLUSION: Second-generation hydrogel coils can be used in a wide spectrum of aneurysms with a risk profile equivalent to bare platinum. Packing density was significantly higher in aneurysms treated with hydrogel coils.TRIAL REGISTRATION: http://www.germanctr.de , DRKS00003132.",
keywords = "Journal Article",
author = "Taschner, {Christian A} and Ren{\'e} Chapot and Vincent Costalat and Paolo Machi and Patrick Courth{\'e}oux and Xavier Barreau and J{\'e}r{\^o}me Berge and Laurent Pierot and Kryzsztof Kadziolka and Betty Jean and Rapha{\"e}l Blanc and Alessandra Biondi and Herv{\'e} Brunel and Sophie Gallas and Ansgar Berlis and Denis Herbreteau and Joachim Berkefeld and Horst Urbach and {El Shikh}, Samer and Jens Fiehler and Hubert Desal and Erika Graf and Alain Bonaf{\'e}",
year = "2016",
month = aug,
doi = "10.1007/s00234-016-1693-y",
language = "English",
volume = "58",
pages = "777--86",
journal = "NEURORADIOLOGY",
issn = "0028-3940",
publisher = "Springer",
number = "8",

}

RIS

TY - JOUR

T1 - GREAT-a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results

AU - Taschner, Christian A

AU - Chapot, René

AU - Costalat, Vincent

AU - Machi, Paolo

AU - Courthéoux, Patrick

AU - Barreau, Xavier

AU - Berge, Jérôme

AU - Pierot, Laurent

AU - Kadziolka, Kryzsztof

AU - Jean, Betty

AU - Blanc, Raphaël

AU - Biondi, Alessandra

AU - Brunel, Hervé

AU - Gallas, Sophie

AU - Berlis, Ansgar

AU - Herbreteau, Denis

AU - Berkefeld, Joachim

AU - Urbach, Horst

AU - El Shikh, Samer

AU - Fiehler, Jens

AU - Desal, Hubert

AU - Graf, Erika

AU - Bonafé, Alain

PY - 2016/8

Y1 - 2016/8

N2 - INTRODUCTION: Hybrid hydrogel-platinum coils (HydroCoil) have proven effective for endovascular aneurysm treatment. To overcome technical limitations (coil stiffness, time restriction for placement), a second generation of softer hydrogel coils has been brought to clinical practice (HydroSoft, HydroFrame). We report on procedural safety and core-lab-assessed angiographic results from an open-label multicenter randomized controlled trial.METHODS: Web-based randomization occurred in 15 medical centers in France and seven in Germany between coil embolization with second-generation hydrogel coils and treatment with any bare platinum coil. Assist devices could be used as clinically required. Primary endpoint is a composite outcome including major aneurysm recurrence and poor clinical outcome at 18 months follow-up.RESULTS: Five hundred thirteen patients were randomized (hydrogel n = 256, bare platinum n = 257). Twenty patients were excluded for missing informed consent and nine patients for treatment related criteria. Four hundred eighty-four patients were analyzed as randomized (hydrogel n = 243, bare platinum n = 241). Two hundred eight had ruptured aneurysms (43 %). Prespecified procedural complications occurred in 58 subjects (hydrogel n = 28, bare platinum n = 30, p = 0.77). The 14-day mortality rate was 2.1 % in both arms of the study. The median calculated packing densities for aneurysms assigned to hydrogel and bare platinum were 39 and 31 % respectively (p < 0.001). No statistically significant differences were found between arms in the post procedural angiographic occlusion rate (p = 0.8).CONCLUSION: Second-generation hydrogel coils can be used in a wide spectrum of aneurysms with a risk profile equivalent to bare platinum. Packing density was significantly higher in aneurysms treated with hydrogel coils.TRIAL REGISTRATION: http://www.germanctr.de , DRKS00003132.

AB - INTRODUCTION: Hybrid hydrogel-platinum coils (HydroCoil) have proven effective for endovascular aneurysm treatment. To overcome technical limitations (coil stiffness, time restriction for placement), a second generation of softer hydrogel coils has been brought to clinical practice (HydroSoft, HydroFrame). We report on procedural safety and core-lab-assessed angiographic results from an open-label multicenter randomized controlled trial.METHODS: Web-based randomization occurred in 15 medical centers in France and seven in Germany between coil embolization with second-generation hydrogel coils and treatment with any bare platinum coil. Assist devices could be used as clinically required. Primary endpoint is a composite outcome including major aneurysm recurrence and poor clinical outcome at 18 months follow-up.RESULTS: Five hundred thirteen patients were randomized (hydrogel n = 256, bare platinum n = 257). Twenty patients were excluded for missing informed consent and nine patients for treatment related criteria. Four hundred eighty-four patients were analyzed as randomized (hydrogel n = 243, bare platinum n = 241). Two hundred eight had ruptured aneurysms (43 %). Prespecified procedural complications occurred in 58 subjects (hydrogel n = 28, bare platinum n = 30, p = 0.77). The 14-day mortality rate was 2.1 % in both arms of the study. The median calculated packing densities for aneurysms assigned to hydrogel and bare platinum were 39 and 31 % respectively (p < 0.001). No statistically significant differences were found between arms in the post procedural angiographic occlusion rate (p = 0.8).CONCLUSION: Second-generation hydrogel coils can be used in a wide spectrum of aneurysms with a risk profile equivalent to bare platinum. Packing density was significantly higher in aneurysms treated with hydrogel coils.TRIAL REGISTRATION: http://www.germanctr.de , DRKS00003132.

KW - Journal Article

U2 - 10.1007/s00234-016-1693-y

DO - 10.1007/s00234-016-1693-y

M3 - SCORING: Journal article

C2 - 27137926

VL - 58

SP - 777

EP - 786

JO - NEURORADIOLOGY

JF - NEURORADIOLOGY

SN - 0028-3940

IS - 8

ER -