Pipeline for uncoilable or failed aneurysms: Results from a multicenter clinical trial

Tibor Becske, David F. Kallmes, Isil Saatci, Cameron G. McDougall, I. Szikora, Giuseppe Lanzino, Christopher J. Moran, Henry H. Woo, Demetrius K. Lopes, Aaron L. Berez, Daniel J. Cher, Adnan H. Siddiqui, Elad I. Levy, Felipe C. Albuquerque, David J. Fiorella, Zsolt Berentei, Miklós Marosfoi, Saruhan H. Cekirge, Peter K. Nelson

Research output: Contribution to journalArticle

490 Citations (Scopus)

Abstract

Purpose: To evaluate the safety and effectiveness of the Pipeline Embolization Device (PED; ev3/Covidien, Irvine, Calif) in the treatment of complex intracranial aneurysms. Materials and Methods: The Pipeline for Uncoilable or Failed Aneurysms is a multicenter, prospective, interventional, single-arm trial of PED for the treatment of uncoilable or failed aneurysms of the internal carotid artery. Institutional review board approval of the HIPAA-compliant study protocol was obtained from each center. After providing informed consent, 108 patients with recently unruptured large and giant wide-necked aneurysms were enrolled in the study. The primary effectiveness endpoint was angiographic evaluation that demonstrated complete aneurysm occlusion and absence of major stenosis at 180 days. The primary safety endpoint was occurrence of major ipsilateral stroke or neurologic death at 180 days. Results: PED placement was technically successful in 107 of 108 patients (99.1%). Mean aneurysm size was 18.2 mm; 22 aneurysms (20.4%) were giant (>25 mm). Of the 106 aneurysms, 78 met the study's primary effectiveness endpoint (73.6%; 95% posterior probability interval: 64.4%-81.0%). Six of the 107 patients in the safety cohort experienced a major ipsilateral stroke or neurologic death (5.6%; 95% posterior probability interval: 2.6%-11.7%). Conclusion: PED offers a reasonably safe and effective treatment of large or giant intracranial internal carotid artery aneurysms, demonstrated by high rates of complete aneurysm occlusion and low rates of adverse neurologic events; even in aneurysms failing previous alternative treatments.

Original languageEnglish
Pages (from-to)858-868
Number of pages11
JournalRadiology
Volume267
Issue number3
DOIs
Publication statusPublished - Jun 2013

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Multicenter Studies
Aneurysm
Clinical Trials
Nervous System
Internal Carotid Artery
Stroke
Health Insurance Portability and Accountability Act
Safety
Research Ethics Committees
Intracranial Aneurysm
Therapeutics
Patient Safety
Informed Consent
Pathologic Constriction
Equipment and Supplies

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Cite this

Becske, T., Kallmes, D. F., Saatci, I., McDougall, C. G., Szikora, I., Lanzino, G., ... Nelson, P. K. (2013). Pipeline for uncoilable or failed aneurysms: Results from a multicenter clinical trial. Radiology, 267(3), 858-868. https://doi.org/10.1148/radiol.13120099

Pipeline for uncoilable or failed aneurysms : Results from a multicenter clinical trial. / Becske, Tibor; Kallmes, David F.; Saatci, Isil; McDougall, Cameron G.; Szikora, I.; Lanzino, Giuseppe; Moran, Christopher J.; Woo, Henry H.; Lopes, Demetrius K.; Berez, Aaron L.; Cher, Daniel J.; Siddiqui, Adnan H.; Levy, Elad I.; Albuquerque, Felipe C.; Fiorella, David J.; Berentei, Zsolt; Marosfoi, Miklós; Cekirge, Saruhan H.; Nelson, Peter K.

In: Radiology, Vol. 267, No. 3, 06.2013, p. 858-868.

Research output: Contribution to journalArticle

Becske, T, Kallmes, DF, Saatci, I, McDougall, CG, Szikora, I, Lanzino, G, Moran, CJ, Woo, HH, Lopes, DK, Berez, AL, Cher, DJ, Siddiqui, AH, Levy, EI, Albuquerque, FC, Fiorella, DJ, Berentei, Z, Marosfoi, M, Cekirge, SH & Nelson, PK 2013, 'Pipeline for uncoilable or failed aneurysms: Results from a multicenter clinical trial', Radiology, vol. 267, no. 3, pp. 858-868. https://doi.org/10.1148/radiol.13120099
Becske, Tibor ; Kallmes, David F. ; Saatci, Isil ; McDougall, Cameron G. ; Szikora, I. ; Lanzino, Giuseppe ; Moran, Christopher J. ; Woo, Henry H. ; Lopes, Demetrius K. ; Berez, Aaron L. ; Cher, Daniel J. ; Siddiqui, Adnan H. ; Levy, Elad I. ; Albuquerque, Felipe C. ; Fiorella, David J. ; Berentei, Zsolt ; Marosfoi, Miklós ; Cekirge, Saruhan H. ; Nelson, Peter K. / Pipeline for uncoilable or failed aneurysms : Results from a multicenter clinical trial. In: Radiology. 2013 ; Vol. 267, No. 3. pp. 858-868.
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abstract = "Purpose: To evaluate the safety and effectiveness of the Pipeline Embolization Device (PED; ev3/Covidien, Irvine, Calif) in the treatment of complex intracranial aneurysms. Materials and Methods: The Pipeline for Uncoilable or Failed Aneurysms is a multicenter, prospective, interventional, single-arm trial of PED for the treatment of uncoilable or failed aneurysms of the internal carotid artery. Institutional review board approval of the HIPAA-compliant study protocol was obtained from each center. After providing informed consent, 108 patients with recently unruptured large and giant wide-necked aneurysms were enrolled in the study. The primary effectiveness endpoint was angiographic evaluation that demonstrated complete aneurysm occlusion and absence of major stenosis at 180 days. The primary safety endpoint was occurrence of major ipsilateral stroke or neurologic death at 180 days. Results: PED placement was technically successful in 107 of 108 patients (99.1{\%}). Mean aneurysm size was 18.2 mm; 22 aneurysms (20.4{\%}) were giant (>25 mm). Of the 106 aneurysms, 78 met the study's primary effectiveness endpoint (73.6{\%}; 95{\%} posterior probability interval: 64.4{\%}-81.0{\%}). Six of the 107 patients in the safety cohort experienced a major ipsilateral stroke or neurologic death (5.6{\%}; 95{\%} posterior probability interval: 2.6{\%}-11.7{\%}). Conclusion: PED offers a reasonably safe and effective treatment of large or giant intracranial internal carotid artery aneurysms, demonstrated by high rates of complete aneurysm occlusion and low rates of adverse neurologic events; even in aneurysms failing previous alternative treatments.",
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AU - Becske, Tibor

AU - Kallmes, David F.

AU - Saatci, Isil

AU - McDougall, Cameron G.

AU - Szikora, I.

AU - Lanzino, Giuseppe

AU - Moran, Christopher J.

AU - Woo, Henry H.

AU - Lopes, Demetrius K.

AU - Berez, Aaron L.

AU - Cher, Daniel J.

AU - Siddiqui, Adnan H.

AU - Levy, Elad I.

AU - Albuquerque, Felipe C.

AU - Fiorella, David J.

AU - Berentei, Zsolt

AU - Marosfoi, Miklós

AU - Cekirge, Saruhan H.

AU - Nelson, Peter K.

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N2 - Purpose: To evaluate the safety and effectiveness of the Pipeline Embolization Device (PED; ev3/Covidien, Irvine, Calif) in the treatment of complex intracranial aneurysms. Materials and Methods: The Pipeline for Uncoilable or Failed Aneurysms is a multicenter, prospective, interventional, single-arm trial of PED for the treatment of uncoilable or failed aneurysms of the internal carotid artery. Institutional review board approval of the HIPAA-compliant study protocol was obtained from each center. After providing informed consent, 108 patients with recently unruptured large and giant wide-necked aneurysms were enrolled in the study. The primary effectiveness endpoint was angiographic evaluation that demonstrated complete aneurysm occlusion and absence of major stenosis at 180 days. The primary safety endpoint was occurrence of major ipsilateral stroke or neurologic death at 180 days. Results: PED placement was technically successful in 107 of 108 patients (99.1%). Mean aneurysm size was 18.2 mm; 22 aneurysms (20.4%) were giant (>25 mm). Of the 106 aneurysms, 78 met the study's primary effectiveness endpoint (73.6%; 95% posterior probability interval: 64.4%-81.0%). Six of the 107 patients in the safety cohort experienced a major ipsilateral stroke or neurologic death (5.6%; 95% posterior probability interval: 2.6%-11.7%). Conclusion: PED offers a reasonably safe and effective treatment of large or giant intracranial internal carotid artery aneurysms, demonstrated by high rates of complete aneurysm occlusion and low rates of adverse neurologic events; even in aneurysms failing previous alternative treatments.

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