The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms

Final results of the pivotal US LVIS trial

David Fiorella, Alan Boulos, Aquilla S. Turk, Adnan H. Siddiqui, Adam Arthur, Orlando Diaz, Demetrius K. Lopes

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Introduction The LVIS stent system (LVIS and LVIS Junior) is a self-expanding, retrievable, microstent system indicated for the treatment of wide-necked cerebral aneurysms (WNAs). The present pivotal study was performed to evaluate the safety and effectiveness of this device. Methods The US LVIS pivotal trial was a prospective, multicenter, single-arm, interventional study conducted at 21 US centers. The study enrolled 153 adults with WNAs of the anterior and posterior circulations. The study was conducted under good clinical practices and included independent adjudication of all adverse events. The primary effectiveness endpoint was defined as successful aneurysm treatment with the LVIS System as evidenced by complete (100%) aneurysm occlusion at 12 months on conventional angiography without retreatment and without significant (≥50%) stenosis of the treated artery at 12 months as determined by an independent core laboratory. The primary safety endpoint was defined as the rate of stroke or death within 30 days, or ipsilateral stroke or neurologic death with 12 months. Results One hundred and fifty-three patients enrolled at 21 investigational sites underwent attempted LVIS-assisted coil embolization. The mean age was 58.3±10.5 years and the majority of the participants (110/153, 71.9%) were female. Fifty-seven aneurysms (57/153, 37.3%) arose from the anterior cerebral artery, 43 (43/153, 28.1%) from the internal carotid artery, 17 (17/153, 11.1%) from the middle cerebral artery, 27 (27/153, 17.6%) from the basilar artery, six (6/153,3.9 %) from the PCA, and two from the vertebral artery. A single aneurysm arose from the superior cerebellar artery. The mean aneurysm dome height was 6.0±2.2 mm and mean width 5.5±2.3 mm. Mean neck width was 4.2±1.4 mm. A total of 22 participants presented for re-treatment of a previously ruptured (>30 days prior to treatment) target aneurysm. The primary effectiveness endpoint was observed in 70.6% (108/153) in the intent to treat population (ITT). Of the evaluable participants with follow-up 12-month angiography, 79.1 % (110/139) demonstrated complete occlusion- 92.1% (128/139) in this population demonstrated ≥95% occlusion and 95% demonstrated ≥90% occlusion (132/139). Eight participants (5.2%, 8/153) had at least one primary safety event in the ITT population. Conclusion The LVIS stent system allows safe and highly effective coil embolization of WNAs. Clinical registration number NCT01793792.

Original languageEnglish (US)
Pages (from-to)357-361
Number of pages5
JournalJournal of neurointerventional surgery
Volume11
Issue number4
DOIs
StatePublished - Apr 1 2019

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Intracranial Aneurysm
Stents
Aneurysm
Safety
Population
Angiography
Therapeutics
Arteries
Stroke
Protective Devices
Anterior Cerebral Artery
Passive Cutaneous Anaphylaxis
Basilar Artery
Retreatment
Vertebral Artery
Middle Cerebral Artery
Internal Carotid Artery
Nervous System
Pathologic Constriction
Neck

All Science Journal Classification (ASJC) codes

  • Surgery
  • Clinical Neurology

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The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms : Final results of the pivotal US LVIS trial. / Fiorella, David; Boulos, Alan; Turk, Aquilla S.; Siddiqui, Adnan H.; Arthur, Adam; Diaz, Orlando; Lopes, Demetrius K.

In: Journal of neurointerventional surgery, Vol. 11, No. 4, 01.04.2019, p. 357-361.

Research output: Contribution to journalArticle

Fiorella, David ; Boulos, Alan ; Turk, Aquilla S. ; Siddiqui, Adnan H. ; Arthur, Adam ; Diaz, Orlando ; Lopes, Demetrius K. / The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms : Final results of the pivotal US LVIS trial. In: Journal of neurointerventional surgery. 2019 ; Vol. 11, No. 4. pp. 357-361.
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title = "The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms: Final results of the pivotal US LVIS trial",
abstract = "Introduction The LVIS stent system (LVIS and LVIS Junior) is a self-expanding, retrievable, microstent system indicated for the treatment of wide-necked cerebral aneurysms (WNAs). The present pivotal study was performed to evaluate the safety and effectiveness of this device. Methods The US LVIS pivotal trial was a prospective, multicenter, single-arm, interventional study conducted at 21 US centers. The study enrolled 153 adults with WNAs of the anterior and posterior circulations. The study was conducted under good clinical practices and included independent adjudication of all adverse events. The primary effectiveness endpoint was defined as successful aneurysm treatment with the LVIS System as evidenced by complete (100{\%}) aneurysm occlusion at 12 months on conventional angiography without retreatment and without significant (≥50{\%}) stenosis of the treated artery at 12 months as determined by an independent core laboratory. The primary safety endpoint was defined as the rate of stroke or death within 30 days, or ipsilateral stroke or neurologic death with 12 months. Results One hundred and fifty-three patients enrolled at 21 investigational sites underwent attempted LVIS-assisted coil embolization. The mean age was 58.3±10.5 years and the majority of the participants (110/153, 71.9{\%}) were female. Fifty-seven aneurysms (57/153, 37.3{\%}) arose from the anterior cerebral artery, 43 (43/153, 28.1{\%}) from the internal carotid artery, 17 (17/153, 11.1{\%}) from the middle cerebral artery, 27 (27/153, 17.6{\%}) from the basilar artery, six (6/153,3.9 {\%}) from the PCA, and two from the vertebral artery. A single aneurysm arose from the superior cerebellar artery. The mean aneurysm dome height was 6.0±2.2 mm and mean width 5.5±2.3 mm. Mean neck width was 4.2±1.4 mm. A total of 22 participants presented for re-treatment of a previously ruptured (>30 days prior to treatment) target aneurysm. The primary effectiveness endpoint was observed in 70.6{\%} (108/153) in the intent to treat population (ITT). Of the evaluable participants with follow-up 12-month angiography, 79.1 {\%} (110/139) demonstrated complete occlusion- 92.1{\%} (128/139) in this population demonstrated ≥95{\%} occlusion and 95{\%} demonstrated ≥90{\%} occlusion (132/139). Eight participants (5.2{\%}, 8/153) had at least one primary safety event in the ITT population. Conclusion The LVIS stent system allows safe and highly effective coil embolization of WNAs. Clinical registration number NCT01793792.",
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T1 - The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms

T2 - Final results of the pivotal US LVIS trial

AU - Fiorella, David

AU - Boulos, Alan

AU - Turk, Aquilla S.

AU - Siddiqui, Adnan H.

AU - Arthur, Adam

AU - Diaz, Orlando

AU - Lopes, Demetrius K.

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N2 - Introduction The LVIS stent system (LVIS and LVIS Junior) is a self-expanding, retrievable, microstent system indicated for the treatment of wide-necked cerebral aneurysms (WNAs). The present pivotal study was performed to evaluate the safety and effectiveness of this device. Methods The US LVIS pivotal trial was a prospective, multicenter, single-arm, interventional study conducted at 21 US centers. The study enrolled 153 adults with WNAs of the anterior and posterior circulations. The study was conducted under good clinical practices and included independent adjudication of all adverse events. The primary effectiveness endpoint was defined as successful aneurysm treatment with the LVIS System as evidenced by complete (100%) aneurysm occlusion at 12 months on conventional angiography without retreatment and without significant (≥50%) stenosis of the treated artery at 12 months as determined by an independent core laboratory. The primary safety endpoint was defined as the rate of stroke or death within 30 days, or ipsilateral stroke or neurologic death with 12 months. Results One hundred and fifty-three patients enrolled at 21 investigational sites underwent attempted LVIS-assisted coil embolization. The mean age was 58.3±10.5 years and the majority of the participants (110/153, 71.9%) were female. Fifty-seven aneurysms (57/153, 37.3%) arose from the anterior cerebral artery, 43 (43/153, 28.1%) from the internal carotid artery, 17 (17/153, 11.1%) from the middle cerebral artery, 27 (27/153, 17.6%) from the basilar artery, six (6/153,3.9 %) from the PCA, and two from the vertebral artery. A single aneurysm arose from the superior cerebellar artery. The mean aneurysm dome height was 6.0±2.2 mm and mean width 5.5±2.3 mm. Mean neck width was 4.2±1.4 mm. A total of 22 participants presented for re-treatment of a previously ruptured (>30 days prior to treatment) target aneurysm. The primary effectiveness endpoint was observed in 70.6% (108/153) in the intent to treat population (ITT). Of the evaluable participants with follow-up 12-month angiography, 79.1 % (110/139) demonstrated complete occlusion- 92.1% (128/139) in this population demonstrated ≥95% occlusion and 95% demonstrated ≥90% occlusion (132/139). Eight participants (5.2%, 8/153) had at least one primary safety event in the ITT population. Conclusion The LVIS stent system allows safe and highly effective coil embolization of WNAs. Clinical registration number NCT01793792.

AB - Introduction The LVIS stent system (LVIS and LVIS Junior) is a self-expanding, retrievable, microstent system indicated for the treatment of wide-necked cerebral aneurysms (WNAs). The present pivotal study was performed to evaluate the safety and effectiveness of this device. Methods The US LVIS pivotal trial was a prospective, multicenter, single-arm, interventional study conducted at 21 US centers. The study enrolled 153 adults with WNAs of the anterior and posterior circulations. The study was conducted under good clinical practices and included independent adjudication of all adverse events. The primary effectiveness endpoint was defined as successful aneurysm treatment with the LVIS System as evidenced by complete (100%) aneurysm occlusion at 12 months on conventional angiography without retreatment and without significant (≥50%) stenosis of the treated artery at 12 months as determined by an independent core laboratory. The primary safety endpoint was defined as the rate of stroke or death within 30 days, or ipsilateral stroke or neurologic death with 12 months. Results One hundred and fifty-three patients enrolled at 21 investigational sites underwent attempted LVIS-assisted coil embolization. The mean age was 58.3±10.5 years and the majority of the participants (110/153, 71.9%) were female. Fifty-seven aneurysms (57/153, 37.3%) arose from the anterior cerebral artery, 43 (43/153, 28.1%) from the internal carotid artery, 17 (17/153, 11.1%) from the middle cerebral artery, 27 (27/153, 17.6%) from the basilar artery, six (6/153,3.9 %) from the PCA, and two from the vertebral artery. A single aneurysm arose from the superior cerebellar artery. The mean aneurysm dome height was 6.0±2.2 mm and mean width 5.5±2.3 mm. Mean neck width was 4.2±1.4 mm. A total of 22 participants presented for re-treatment of a previously ruptured (>30 days prior to treatment) target aneurysm. The primary effectiveness endpoint was observed in 70.6% (108/153) in the intent to treat population (ITT). Of the evaluable participants with follow-up 12-month angiography, 79.1 % (110/139) demonstrated complete occlusion- 92.1% (128/139) in this population demonstrated ≥95% occlusion and 95% demonstrated ≥90% occlusion (132/139). Eight participants (5.2%, 8/153) had at least one primary safety event in the ITT population. Conclusion The LVIS stent system allows safe and highly effective coil embolization of WNAs. Clinical registration number NCT01793792.

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