Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device

David Fiorella, Adam Arthur, Alan Boulos, Orlando Diaz, Pascal Jabbour, Lee Pride, Aquilla S. Turk, Henry H. Woo, Colin Derdeyn, John Millar, Andrew Clifton

Research output: Contribution to journalArticle

34 Citations (Scopus)

Abstract

Introduction The low-profile visualized intraluminal support (LVIS) device is a new, braided, intracranial microstent designed for stent-assisted coiling. Objective To present the results of a single-arm, prospective, multicenter trial of the LVIS for treatment of wide-necked intracranial aneurysms. Methods 31 patients with unruptured, wide-necked (neck ≥4 mm or dome:neck ratio ≤2) intracranial aneurysms were treated with the LVIS device and bare platinum coils at six US centers (investigational device exemption G110014). Clinical follow-up was conducted at 30 days and 6 months. Angiographic follow-up was performed at 6 months. The primary safety endpoint was any major stroke or death within 30 days or major ipsilateral stroke or neurological death within 6 months. 'Probable benefit' was defined as ≥90% angiographic occlusion at 6 months. An independent core laboratory adjudicated the angiographic results. An independent clinical events committee adjudicated the clinical endpoints. Results Average aneurysm size was 7.2 mm (SD 3.8) and average neck width was 4.6 mm (SD 1.8). 68% of patients had a dome:neck ratio ≤2. LVIS placement was technically successful in 29/31 patients (93.5%). No primary safety endpoints occurred during the study (0%). No patient had a higher modified Rankin Score at 6 months than at baseline. 26/28 (92.9%) treated aneurysms with 6-month angiographic follow-up demonstrated ≥90% angiographic occlusion. 21/28 (75%) were completely occluded at follow-up. Conclusions The LVIS device facilitated the coil embolization of wide-necked intracranial aneurysms with high rates of technical success, an excellent safety profile, and very high rates of complete and near-complete occlusion at follow-up. Trial registration number NCT01541254.

Original languageEnglish (US)
Pages (from-to)894-897
Number of pages4
JournalJournal of NeuroInterventional Surgery
Volume8
Issue number9
DOIs
StatePublished - Sep 1 2016

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Compassionate Use Trials
Intracranial Aneurysm
Neck
Equipment and Supplies
Safety
Aneurysm
Stroke
Platinum
Multicenter Studies
Stents

Keywords

  • Aneurysm
  • Device
  • Stent

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

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Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device. / Fiorella, David; Arthur, Adam; Boulos, Alan; Diaz, Orlando; Jabbour, Pascal; Pride, Lee; Turk, Aquilla S.; Woo, Henry H.; Derdeyn, Colin; Millar, John; Clifton, Andrew.

In: Journal of NeuroInterventional Surgery, Vol. 8, No. 9, 01.09.2016, p. 894-897.

Research output: Contribution to journalArticle

Fiorella, D, Arthur, A, Boulos, A, Diaz, O, Jabbour, P, Pride, L, Turk, AS, Woo, HH, Derdeyn, C, Millar, J & Clifton, A 2016, 'Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device', Journal of NeuroInterventional Surgery, vol. 8, no. 9, pp. 894-897. https://doi.org/10.1136/neurintsurg-2015-011937
Fiorella, David ; Arthur, Adam ; Boulos, Alan ; Diaz, Orlando ; Jabbour, Pascal ; Pride, Lee ; Turk, Aquilla S. ; Woo, Henry H. ; Derdeyn, Colin ; Millar, John ; Clifton, Andrew. / Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device. In: Journal of NeuroInterventional Surgery. 2016 ; Vol. 8, No. 9. pp. 894-897.
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abstract = "Introduction The low-profile visualized intraluminal support (LVIS) device is a new, braided, intracranial microstent designed for stent-assisted coiling. Objective To present the results of a single-arm, prospective, multicenter trial of the LVIS for treatment of wide-necked intracranial aneurysms. Methods 31 patients with unruptured, wide-necked (neck ≥4 mm or dome:neck ratio ≤2) intracranial aneurysms were treated with the LVIS device and bare platinum coils at six US centers (investigational device exemption G110014). Clinical follow-up was conducted at 30 days and 6 months. Angiographic follow-up was performed at 6 months. The primary safety endpoint was any major stroke or death within 30 days or major ipsilateral stroke or neurological death within 6 months. 'Probable benefit' was defined as ≥90{\%} angiographic occlusion at 6 months. An independent core laboratory adjudicated the angiographic results. An independent clinical events committee adjudicated the clinical endpoints. Results Average aneurysm size was 7.2 mm (SD 3.8) and average neck width was 4.6 mm (SD 1.8). 68{\%} of patients had a dome:neck ratio ≤2. LVIS placement was technically successful in 29/31 patients (93.5{\%}). No primary safety endpoints occurred during the study (0{\%}). No patient had a higher modified Rankin Score at 6 months than at baseline. 26/28 (92.9{\%}) treated aneurysms with 6-month angiographic follow-up demonstrated ≥90{\%} angiographic occlusion. 21/28 (75{\%}) were completely occluded at follow-up. Conclusions The LVIS device facilitated the coil embolization of wide-necked intracranial aneurysms with high rates of technical success, an excellent safety profile, and very high rates of complete and near-complete occlusion at follow-up. Trial registration number NCT01541254.",
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AU - Fiorella, David

AU - Arthur, Adam

AU - Boulos, Alan

AU - Diaz, Orlando

AU - Jabbour, Pascal

AU - Pride, Lee

AU - Turk, Aquilla S.

AU - Woo, Henry H.

AU - Derdeyn, Colin

AU - Millar, John

AU - Clifton, Andrew

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N2 - Introduction The low-profile visualized intraluminal support (LVIS) device is a new, braided, intracranial microstent designed for stent-assisted coiling. Objective To present the results of a single-arm, prospective, multicenter trial of the LVIS for treatment of wide-necked intracranial aneurysms. Methods 31 patients with unruptured, wide-necked (neck ≥4 mm or dome:neck ratio ≤2) intracranial aneurysms were treated with the LVIS device and bare platinum coils at six US centers (investigational device exemption G110014). Clinical follow-up was conducted at 30 days and 6 months. Angiographic follow-up was performed at 6 months. The primary safety endpoint was any major stroke or death within 30 days or major ipsilateral stroke or neurological death within 6 months. 'Probable benefit' was defined as ≥90% angiographic occlusion at 6 months. An independent core laboratory adjudicated the angiographic results. An independent clinical events committee adjudicated the clinical endpoints. Results Average aneurysm size was 7.2 mm (SD 3.8) and average neck width was 4.6 mm (SD 1.8). 68% of patients had a dome:neck ratio ≤2. LVIS placement was technically successful in 29/31 patients (93.5%). No primary safety endpoints occurred during the study (0%). No patient had a higher modified Rankin Score at 6 months than at baseline. 26/28 (92.9%) treated aneurysms with 6-month angiographic follow-up demonstrated ≥90% angiographic occlusion. 21/28 (75%) were completely occluded at follow-up. Conclusions The LVIS device facilitated the coil embolization of wide-necked intracranial aneurysms with high rates of technical success, an excellent safety profile, and very high rates of complete and near-complete occlusion at follow-up. Trial registration number NCT01541254.

AB - Introduction The low-profile visualized intraluminal support (LVIS) device is a new, braided, intracranial microstent designed for stent-assisted coiling. Objective To present the results of a single-arm, prospective, multicenter trial of the LVIS for treatment of wide-necked intracranial aneurysms. Methods 31 patients with unruptured, wide-necked (neck ≥4 mm or dome:neck ratio ≤2) intracranial aneurysms were treated with the LVIS device and bare platinum coils at six US centers (investigational device exemption G110014). Clinical follow-up was conducted at 30 days and 6 months. Angiographic follow-up was performed at 6 months. The primary safety endpoint was any major stroke or death within 30 days or major ipsilateral stroke or neurological death within 6 months. 'Probable benefit' was defined as ≥90% angiographic occlusion at 6 months. An independent core laboratory adjudicated the angiographic results. An independent clinical events committee adjudicated the clinical endpoints. Results Average aneurysm size was 7.2 mm (SD 3.8) and average neck width was 4.6 mm (SD 1.8). 68% of patients had a dome:neck ratio ≤2. LVIS placement was technically successful in 29/31 patients (93.5%). No primary safety endpoints occurred during the study (0%). No patient had a higher modified Rankin Score at 6 months than at baseline. 26/28 (92.9%) treated aneurysms with 6-month angiographic follow-up demonstrated ≥90% angiographic occlusion. 21/28 (75%) were completely occluded at follow-up. Conclusions The LVIS device facilitated the coil embolization of wide-necked intracranial aneurysms with high rates of technical success, an excellent safety profile, and very high rates of complete and near-complete occlusion at follow-up. Trial registration number NCT01541254.

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