Treatment of wide-necked intracranial aneurysms is associated with higher recanalization and complication rates; however, the most commonly used methods are not specifically designed to work in bifurcation lesions. To address these issues, the authors describe the evolution in the design and use of the eCLIPs (Endovascular Clip System) device, a novel hybrid stent-like assist device with flow diverter properties that was first described in 2008.
A registry was established covering 13 international centers at which patients were treated with the second-generation eCLIPs device. Aneurysm morphology and rupture status, device neck coverage, coil retention, and procedural and late morbidity and mortality were recorded. For those patients who had undergone successful implantation more than 6 months earlier, the final imaging and clinical follow-up results and need for re-treatment were recorded.
Thirty-three patients were treated between June 2013 and September 2015. Twenty-five (76%) patients had successful placement of an eCLIPs device; 23 (92%) of these 25 patients had complete data. Eight cases of nondeployment occurred during the 1st year of use, consistent with a learning curve; no failures of deployment occurred thereafter. Two periprocedural transient ischemic attacks and 2 asymptomatic thrombotic events occurred. Twenty-one (91%) of 23 patients underwent follow-up at an average of 8 months (range 3–18 months); 9 (42.9%) of these 21 patients demonstrated an improvement in Raymond grade at follow-up; no cases of worsening Raymond grade were recorded, and 17 (81.0%) patients sustained a modified Raymond-Roy Classification class of I or II angiographic result at follow-up. Two delayed ruptures were recorded, both in previously coiled, symptomatic giant aneurysms where the device was used as a part of a salvage strategy.
The second-generation eCLIPs device is a viable treatment option for bifurcation aneurysms. The aneurysm occlusion rates in this initial clinical series are comparable to the initial experience with other bifurcation support devices.
Correspondence Thomas R. Marotta, Diagnostic and Therapeutic Neuroradiology, St. Michael's Hospital, 30 Bond St., Toronto, ON M5B 1W8, Canada. email: email@example.com.
INCLUDE WHEN CITING Published online March 17, 2017; DOI: 10.3171/2016.10.JNS161731.
Drs. Chiu and Marotta contributed equally to this work.
Disclosures The authors report the following. Dr. De Vries: consultant for Evasc; and principal investigator for the EESIS trial, a multicenter postmarketing study evaluating the safety, technical feasibility, and efficacy of the eCLIPs family of products for the treatment of bifurcation intracranial aneurysms, an industry sponsored trial (Evasc). Dr. O'Kelly: proctor for Pipeline Embolization Device insertion for Medtronic. Dr. Riina: medical advisor to and financial stakeholder of Evasc Medical Systems. Mr. McDougall: ownership in, consultant for, and employed by Evasc Medical Systems. Mr. Tippett: employed by Evasc Medical Systems. Ms. Wan: employed by Evasc Medical Systems. Dr. Marotta: direct stock ownership in Evasc, and medical consultant and proctor for eCLIPs, part of Evasc.
Aguilar-PérezMKurreWFischerSBäznerHHenkesH: Coil occlusion of wide-neck bifurcation aneurysms assisted by a novel intra- to extra-aneurysmatic neck-bridging device (pCONus): initial experience. AJNR Am J Neuroradiol35:965–9712014
HettsSWTurkAEnglishJDDowdCFMoccoJPrestigiacomoC: Stent-assisted coiling versus coiling alone in unruptured intracranial aneurysms in the matrix and platinum science trial: safety, efficacy, and mid-term outcomes. AJNR Am J Neuroradiol35:698–7052014
MarottaTRGunnarssonTPennIRicciDRMcDougallIMarkoA: A novel endovascular clip system for the treatment of intracranial aneurysms: technology, concept, and initial experimental results. Laboratory investigation. J Neurosurg108:1230–12402008
PierotLCognardCSpelleLMoretJ: Safety and efficacy of balloon remodeling technique during endovascular treatment of intracranial aneurysms: critical review of the literature. AJNR Am J Neuroradiol33:12–152012
PierotLLiebigTSychraVKadziolkaKDornFStrasillaC: Intrasaccular flow-disruption treatment of intracranial aneurysms: preliminary results of a multicenter clinical study. AJNR Am J Neuroradiol33:1232–12382012