O-013 Cerecyte coil trial: the clinical outcome of endovascular coiling in patients with ruptured and unruptured intracranial aneurysms treated with Cerecyte coils compared with bare platinum coils. Results of a prospective randomized trial

2010 ◽  
Vol 2 (Suppl_1) ◽  
pp. A6-A7 ◽  
Author(s):  
A. Molyneux ◽  
S. Coley ◽  
M. Sneade ◽  
Z. Mehta
Keyword(s):  
Clinical Outcome ◽  
Randomized Trial ◽  
Intracranial Aneurysms ◽  
Prospective Randomized Trial ◽  
Endovascular Coiling ◽  
Unruptured Intracranial Aneurysms ◽  
Bare Platinum Coils ◽  
Platinum Coils

scholarly journals C.03 Surgical clipping or endovascular coiling for unruptured intracranial aneurysms: a pragmatic randomized trial

2017 ◽  
Vol 44 (S2) ◽  
pp. S12-S13
Author(s):  
TE Darsaut ◽  
Keyword(s):  
Randomized Trial ◽  
Intracranial Aneurysms ◽  
Primary Outcome ◽  
Morbidity And Mortality ◽  
Neurological Deficits ◽  
Endovascular Coiling ◽  
Surgical Clipping ◽  
Microsurgical Clipping ◽  
Unruptured Intracranial Aneurysms ◽  
One Year

Background: Unruptured intracranial aneurysms (UIAs) are treated using endovascular treatment or microsurgical clipping. The safety and efficacy of treatments have not been compared in a randomized trial. Methods: We randomly allocated clipping or coiling to patients with 3-25mm UIAs judged treatable both ways. The primary outcome was treatment failure, defined as: initial failure of aneurysm treatment, intracranial hemorrhage or residual aneurysm on one year imaging. Secondary outcomes included neurological deficits following treatment, hospitalization >5 days, overall morbidity and mortality and angiographic results at one year. Results: 136 patients were enrolled from 2010 through 2016 and 134 patients were treated. The one-year primary outcome, available for 104 patients, was reached in 5/48 (10.4% (4.5%-22.2%)) patients allocated surgical clipping, and 10/56 (17.9% (10.0%-29.8%)) patients allocated endovascular coiling (OR: 0.54 (0.13, 1.90), P=0.40). Morbidity and mortality (mRS>2) at one year occurred in 2/48 (4.2% (1.2%-14.0%)) and 2/56 (3.6% (1.0%-12.1%)) patients allocated clipping and coiling respectively. New neurological deficits (15/65 vs 6/69; OR: 3.12 (1.05, 10.57), P=0.031), and hospitalizations beyond 5 days (30/65 vs 6/69; OR: 8.85 (3.22,28.59), P=0.0001) were more frequent after clipping. Conclusions: Surgical clipping led to greater initial treatment-related morbidity than endovascular coiling. At one year, the superior efficacy of clipping remains unproven and in need of randomized evidence.

Abstract W P75: New Generation Hydrogel Endovascular Aneurysm Treatment Trial

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Samer G Zammar ◽  
Youssef J Hamade ◽  
Jennifer Ward ◽  
Byron K Yip ◽  
Nicole Reinholdt ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Packing Density ◽  
Intracranial Aneurysms ◽  
Recurrence Rates ◽  
2Nd Generation ◽  
Aneurysm Treatment ◽  
Unruptured Intracranial Aneurysms ◽  
Bare Platinum Coils ◽  
New Generation ◽  
Platinum Coils

Background: Endovascular treatment of intracranial aneurysms has seen significant advances. One major limitation of the endovascular approach is durability of treatment and aneurysm recanalization. To address this issue, one approach was the development of hydrogel-coated coils. Hydrogel expands upon exposure to blood and thus enhances coil packing density. Higher initial coil packing density may potentially result in lower rates of recurrence. Hypothesis: The 2nd Generation HydroCoil Embolic System allows for a higher packing density, higher initial occlusion, lower recanalization, and lower retreatment rates compared to bare platinum coils. Objective: To compare clinical and angiographic outcomes (initial complete occlusion, recanalization, retreatment, and adverse event rates) in patients receiving the 2nd Generation HydroCoil Embolic System versus patients receiving bare platinum coils. Methods: This is a randomized, controlled, multicenter, post-market clinical trial. Subjects between 18 and 75 years of age with ruptured or unruptured intracranial aneurysms (3-14 mm in size) who are amenable to endovascular treatment are randomly assigned 1:1 to one of two treatment arms: 1) the HydroCoil Embolic System (HES), or 2) bare platinum coils. No bioactive coils, 1st generation HydroCoils or liquid embolics are allowed in the study. In the HES arm, up to 10% of total coil length using bare platinum is allowed if deemed necessary by the investigator. Any type of bare platinum coil may be utilized in the bare platinum arm. Assist-devices can be used at the discretion of the investigator. The duration of the open enrollment phase will be 24 months or until the required number of subjects are enrolled (n = 600). Each subject will have a post-procedure follow-up of at least 18 months. Subjects will be recruited from up to 50 national and international centers. Each Investigational Site will be expected to enroll at least 20 Subjects. Results: A total of 368 patients have been enrolled to date in the study. The study is still ongoing. Conclusions: A limitation of endovascular aneurysm treatment is recurrence. This trial aims to answer the question of whether the new generation hydrogel coil reduces recurrence rates when compared to bare platinum coils.

scholarly journals Analysis of risk factors for perifocal oedema after endovascular embolization of unruptured intracranial arterial aneurysms

2015 ◽  
Vol 49 (4) ◽  
pp. 341-346 ◽  
Author(s):  
Snezana Lukic ◽  
Slobodan Jankovic ◽  
Katarina Surlan Popovic ◽  
Dragic Bankovic ◽  
Peter Popovic ◽  
...  
Keyword(s):  
Risk Factors ◽  
Intracranial Aneurysms ◽  
Smoking Habit ◽  
Interventional Neuroradiology ◽  
Endovascular Embolization ◽  
Outcome Variable ◽  
Endovascular Coiling ◽  
Unruptured Intracranial Aneurysms ◽  
Perifocal Oedema ◽  
Platinum Coils

Abstract Background. Endovascular embolization is a treatment of choice for the management of unruptured intracranial aneurysms, but sometimes is complicated with perianeurysmal oedema. The aim of our study was to establish incidence and outcomes of perianeurysmal oedema after endovascular coiling of unruptured intracranial aneurysms, and to reveal possible risk factors for development of this potentially serious complication. Methods. In total 119 adult patients with endovascular embolization of unruptured intracranial aneurysm (performed at Department for Interventional Neuroradiology, Clinical Center, Kragujevac, Serbia) were included in our study. The embolizations were made by electrolite-detachable platinum coils: pure platinum, hydrophilic and combination of platinum and hydrophilic coils. Primary outcome variable was perianeurysmal oedema visualized by magnetic resonance imaging (MRI) 7, 30 and 90 days after the embolization. Results. The perianurysmal oedema appeared in 47.6% of patients treated with hydrophilic coils, in 21.6% of patients treated with platinum coils, and in 53.8% of those treated with mixed type of the coils. The multivariate logistic regression showed that variables associated with occurrence of perianeurysmal oedema are volume of the aneurysm, hypertension, diabetes and smoking habit. Hypertension is the most important independent predictor of the perianeurysmal oedema, followed by smoking and diabetes. Conclusions. The results of our study suggest that older patients with larger unruptured intracranial aneurysms, who suffer from diabetes mellitus and hypertension, and have the smoking habit, are under much higher risk of having perianeurysmal oedema after endovascular coiling.

scholarly journals A Randomized Trial on the Safety and Efficacy of Endovascular Treatment of Unruptured Intracranial Aneurysms is Feasible

2004 ◽  
Vol 10 (2) ◽  
pp. 103-112 ◽  
Author(s):  
J. Raymond ◽  
M. Chagnon ◽  
J-P Collet ◽  
F. Guilbert ◽  
A. Weill ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Randomized Trial ◽  
Intracranial Aneurysms ◽  
Controlled Trial ◽  
Endovascular Coiling ◽  
Composite Outcome ◽  
Entire Study ◽  
Safety And Efficacy ◽  
Unruptured Intracranial Aneurysms ◽  
Potential Benefits

The safety and efficacy of endovascular treatment of unruptured intracranial aneurysms remain undetermined. A randomized trial may be the best way to demonstrate the potential benefits of endovascular management. We propose a randomized, prospective, controlled trial comparing the incidence of subarachnoid haemorrage of patients treated by endovascular coiling as compared to conservative management. We would also study a composite outcome combining SAH and the morbidity of treatment. All patients with one or more unruptured aneurysm >> 3 mm eligible for endovascular treatment would be proposed to participate. The study would be conducted in 40–50 centres. The entire study would enrol 1800 patients, recruited over three years and followed for five years, but would be preceded by a feasibility study on 200 patients. A randomized trial comparing endovascular and conservative treatment could have an important impact on the clinical management of intracranial aneurysms

scholarly journals Fibered Electrolytically Detachable Platinum Coils Used for the Endovascular Treatment of Intracranial Aneurysms

2004 ◽  
Vol 10 (1) ◽  
pp. 5-26 ◽  
Author(s):  
T. Liebig ◽  
H. Henkes ◽  
S. Fischer ◽  
W. Weber ◽  
E. Miloslavski ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Clinical Outcome ◽  
Endovascular Treatment ◽  
Intracranial Aneurysms ◽  
Statistical Significance ◽  
Matched Pairs ◽  
Occlusion Rate ◽  
Bare Platinum Coils ◽  
Platinum Coils

Between 1992 and 2003, a total of 2029 aneurysms in 1748 patients were treated by endovascular occlusion with electrolytically detachable coils. In this series, electrolytically detachable platinum coils with Nylon fibers (Sapphire Detachable Coil System, MTI, Irvine, CA, USA) were used in 474 aneurysms solely or in combination with bare coils from various manufacturers. To determine the safety and clinical efficacy of Nylon fibered coils for the endovascular treatment of intracranial aneurysms in comparison to bare platinum coils a thorough retrospective statistical analysis by means of logistic regression and matched pairs analysis was performed. Only treatments with data for all matching variables were used, resulting in 421 matched pairs. The analysis was performed with respect to clinical status and numerous parameters concerning individual aneurysm characteristics (e.g., location, neck width, fundus diameter). Treatment-related parameters included the use and percentage of fibered coils, occlusion rate, procedural complications, early clinical outcome and Glasgow Outcome Scale (GOS) scores. Finally, long-term follow-up results (particularly recurrence, cause of recurrence and post treatment haemorrhage) were evaluated. Both logistic regression and matched pairs analysis sho wed a statistically improved occlusion rate if fibered coils had been used (96% largely occluded with the use of fibered coils vs. 84–85% with the exclusive use of bare coils). However, the amount of fibered coils calculated as percentage of coil length did not seem to have significant impact. Procedures with fibered coils did not lead to a higher rate of thromboembolic events (8.0% for fibered vs. 10.5% for bare coils). The apparently better clinical outcome in the group treated with fibered coils determined by both postprocedural outcome and GOS, did not reach statistical significance. Analysis of the anatomical properties showed no differences between the groups treated with bare and fibered coils in terms of neck width, fundus diameter, and anatomic location. As expected, a higher occlusion rate was achieved in aneurysms with smaller neck and fundus independent from the type of coil used. On follow up angiography, there was an apparently lower rate of recurrence secondary to coil compaction in the group treated with fibered coils, but these data were compromised by the fact that up to date only about one third of 474 aneurysms treated with fibered coils had undergone angiographic follow-up and this did not reach statistical significance. From our experiences, we conclude that the use of fibered electrolytically detachable platinum coils in aneurysm treatment leads to significantly improved occlusion rates compared to the sole use of bare platinum coils. We hope that with increasing follow-up data we will be able to confirm that the apparently reduced recurrence rates for aneurysms treated with fibered coils can be proven with statistical significance.

Sign in / Sign up

Export Citation Format

Share Document