The Safety and Effectiveness of the Contour Neurovascular System (Contour) for the Treatment of Bifurcation Aneurysms: The CERUS Study.
Neurosurgery
; 90(3): 270-277, 2022 03 01.
Article
in En
| MEDLINE
| ID: mdl-35113830
ABSTRACT
BACKGROUND:
The Contour is a novel intra-aneurysmal flow disrupting device to treat intracranial aneurysms.OBJECTIVE:
To evaluate the safety and effectiveness of the Contour device for treatment of nonruptured intracranial bifurcation aneurysms through a prospective, multicenter, single-arm study.METHODS:
Thirty-four patients were enrolled. Primary end points were successful occlusion at 6 mo for efficacy and any major stroke or nonaccidental death up to 30 d or major disabling stroke within 6 mo for safety. Secondary end points were occlusion at 12 mo, retreatment rate, procedure time, and procedure-related/device-related adverse events. Procedural and follow-up imaging was reviewed by an independent core laboratory. Adverse events were reviewed and adjudicated by a clinical events committee.RESULTS:
In total, 32 of 34 aneurysms were successfully implanted and, 2 of 34 in the intention-to-treat (ITT) group did not receive the Contour and were excluded from follow-up after 30 d. In addition, 2 of 32 were lost to angiographic follow-up and regarded as treatment failure. The primary safety end point was met in 2 patients in the ITT group. In the perprotocol (PP) group, complete occlusion was seen in 14 of 32 (44%) at 6 mo and 22 of 32 (69%) at 12 mo. Adequate occlusion (Raymond-Roy [RR] 1 and 2) was reached in 84% at a last available follow-up. One patient from the ITT group and 1 from the PP group received additional treatment during follow-up.CONCLUSION:
The Contour seems to be both safe and effective in the treatment of intracranial bifurcation aneurysms.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Intracranial Aneurysm
/
Stroke
/
Embolization, Therapeutic
/
Endovascular Procedures
Type of study:
Observational_studies
/
Prognostic_studies
Limits:
Humans
Language:
En
Journal:
Neurosurgery
Year:
2022
Document type:
Article
Affiliation country: