scholarly journals New Devices Designed to Improve the Long-Term Results of Endovascular Treatment of Intracranial Aneurysms

2004 ◽  
Vol 10 (2) ◽  
pp. 93-102 ◽  
Author(s):  
J. Raymond ◽  
P. Leblanc ◽  
M. Chagnon ◽  
G. Gévry ◽  
J.-P. Collet ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Intracranial Aneurysms ◽  
Controlled Trial ◽  
Long Term Results ◽  
Secondary Outcome ◽  
Endovascular Coiling ◽  
Double Blind Study ◽  
Double Blind ◽  
Term Efficacy

Endovascular coiling can improve the outcome of patients with ruptured intracranial aneurysms, but angiographic recurrences are frequent compared to surgical clipping. New coils or devices have been introduced to improve long-term results of endovascular treatment but none have been the object of a valid clinical trial. We have proposed a multicentric randomized double-blind study comparing radioactive and standard coil occlusion of aneurysms. The purpose of this article is to review issues that are specific to the design of clinical trials to assess embolic agents that could improve the long-term efficacy of endovascular treatment of intracranial aneurysms. The proposed trial is a randomized, multi-center, prospective, controlled trial comparing the new generation coils to standard platinum coils. Blinding, if at all possible, is preferable to minimize bias, at least for follow-up angiographic studies that should cover a period of 18 months. All patients with an intracranial aneurysm eligible for endovascular treatment would be proposed to participate. The study would enrol approximately 500 patients equally divided between the two groups, recruited within two years, to demonstrate a decrease in the recurrence rate, the primary outcome measure, from 20% to 10%. Secondary outcome measures should assure that complications, initial clinical and angiographic results remain unchanged. Independent data safety and monitoring committees are crucial to the credibility of trials and to ensure scientific rigor and objectivity. The scientific demonstration of an improved long-term efficacy, without significant compromise regarding safety, is mandatory before considering the widespread use of a new embolic device for the endovascular treatment of aneurysms.

scholarly journals Early experience with the Penumbra SMART coil in the endovascular treatment of intracranial aneurysms: Safety and efficacy

2016 ◽  
Vol 22 (6) ◽  
pp. 654-658 ◽  
Author(s):  
Christopher J Stapleton ◽  
Collin M Torok ◽  
Aman B Patel
Keyword(s):  
Endovascular Treatment ◽  
Intracranial Aneurysms ◽  
Thromboembolic Complication ◽  
Flow Diversion ◽  
Long Term Results ◽  
Conformational Structure ◽  
Safety And Efficacy ◽  
Endovascular Coil Embolization ◽  
Male Patients

Background Penumbra SMART coils differ from traditional microcoils used for endovascular coil embolization of intracranial aneurysms (IAs) in that they (1) become progressively softer from their distal to proximal end, rather than being of uniform stiffness, (2) have a tight conformational structure, and (3) have a more robust stretch-resistance platform. These properties aid in preventing microcatheter prolapse and coil herniation during coil deployment and in filling small pockets of the aneurysm sac. Objective/Methods To determine the safety and efficacy of this device, the records of 17 consecutive patients with IAs treated with SMART coils were retrospectively analyzed. Results Thirteen female and four male patients were identified. Eleven patients presented with subarachnoid hemorrhage, four had recurrent aneurysms, and two had incidentally discovered aneurysms. Twelve aneurysms (two of which were recurrent) were treated with stand-alone coiling, three were treated with stent-assisted coiling, and two with flow diversion with adjuvant coiling. Microcatheter prolapse occurred in one case of a recurrent aneurysm, due to mechanical limitations imposed by a stent placed during prior coiling. Raymond-Roy Occlusion Classification (RROC) I or II occlusion was achieved in 12 aneurysms, including all 10 undergoing primary stand-alone coiling. Of the five RROC III occlusions, two were expected given treatment with flow diversion, while the other three occurred in complex, recurrent aneurysms. One patient suffered a thromboembolic complication of unclear clinical significance. Conclusions The Penumbra SMART coil is a safe and effective device for the endovascular treatment of IAs. Follow-up studies are required to establish long-term results.

Endovascular treatment of intracranial aneurysms with the Woven EndoBridge device: mid term and long term results

2017 ◽  
Vol 10 (2) ◽  
pp. 127-132 ◽  
Author(s):  
Benjamin Mine ◽  
Alexandra Goutte ◽  
Denis Brisbois ◽  
Boris Lubicz
Keyword(s):  
Endovascular Treatment ◽  
Intracranial Aneurysms ◽  
Long Term Results ◽  
Results Of Treatment ◽  
Long Term Follow Up ◽  
Device Placement ◽  
Woven Endobridge ◽  
Web Device

PurposeTo evaluate the clinical and anatomical results of treatment of intracranial aneurysms (IA) with the Woven EndoBridge (WEB) device, with emphasis on mid term and long term follow-up.MethodsBetween November 2010 and November 2015, we retrospectively identified, in our prospectively maintained database, all patients treated by WEB device placement for an IA at three institutions. Clinical charts, procedural data, and angiographic results were reviewed.Results48 patients with 49 IAs were identified. There were 35 women and 13 men with a mean age of 57 years (range 35–76 years). All IA were wide necked. Mean aneurysm size was 8.6 mm. There were 44 unruptured IA and 5 ruptured IA. During endovascular treatment (EVT), adjunctive devices were used in 22.4% of procedures. A good clinical outcome (modified Rankin Scale score ≤2) was achieved in 44/48 patients (92%). There was no mortality. Mean follow-up was 25 months (range 3–72 months; median 24 months). Between mid term and long term follow-up, occlusion was stable in 19/23 IA (82.6%), improved in 2/23 IA (8.7%), and worsened in 2/23 IA (8.7%). Retreatment was performed in 8/49 IA (16.3%). At the latest available follow-up, there were 34/47 (72.3%) complete occlusions and 13/47 (27.7%) neck remnants.ConclusionsOur study suggests that EVT of IA with the WEB device provides adequate and stable long term occlusion.

Switching from long-term benzodiazepine therapy to pregabalin in patients with generalized anxiety disorder: a double-blind, placebo-controlled trial

2011 ◽  
Vol 26 (4) ◽  
pp. 461-470 ◽  
Author(s):  
Sallie J Hadley ◽  
Francine S Mandel ◽  
Edward Schweizer
Keyword(s):  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Rating Scale ◽  
Controlled Trial ◽  
Generalized Anxiety ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Hamilton Anxiety Rating Scale

To evaluate the efficacy of pregabalin in facilitating taper off chronic benzodiazepines, outpatients ( N = 106) with a lifetime diagnosis of generalized anxiety disorder (current diagnosis could be subthreshold) who had been treated with a benzodiazepine for 8–52 weeks were stabilized for 2–4 weeks on alprazolam in the range of 1–4 mg/day. Patients were then randomized to 12 weeks of double-blind treatment with either pregabalin 300–600 mg/day or placebo while undergoing a gradual benzodiazepine taper at a rate of 25% per week, followed by a 6-week benzodiazepine-free phase during which they continued double-blind study treatment. Outcome measures included ability to remain benzodiazepine-free (primary) as well as changes in Hamilton Anxiety Rating Scale (HAM)-A and Physician Withdrawal Checklist (PWC). At endpoint, a non-significant higher proportion of patients remained benzodiazepine-free receiving pregabalin compared with placebo (51.4% vs 37.0%). Treatment with pregabalin was associated with significantly greater endpoint reduction in the HAM-A total score versus placebo (−2.5 vs +1.3; p < 0.001), and lower endpoint mean PWC scores (6.5 vs 10.3; p = 0.012). Thirty patients (53%) in the pregabalin group and 19 patients (37%) in the placebo group completed the study, reducing the power to detect a significant difference on the primary outcome. The results on the anxiety and withdrawal severity measures suggest that switching to pregabalin may be a safe and effective method for discontinuing long-term benzodiazepine therapy.

scholarly journals Low Dose Niacin Versus Placebo Treatment for Parkinson's Disease: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Chandramohan Wakade ◽  
Raymond Chong ◽  
Marissa Seamon ◽  
Sharad Purohit ◽  
Bababihari Giri ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Low Dose ◽  
Rating Scale ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Double Blind Study ◽  
Double Blind ◽  
One Year ◽  
Time Point

Abstract Background Parkinson's Disease (PD) patients have lower niacin levels compared to their spouses. The main objective was to study low-dose daily niacin supplementation on motor symptoms in Parkinson's disease subjects. Methods Forty-Seven PD patients were randomly assigned to receive low-dose niacin or placebo in a randomized, double-blind study for the first six months. After the double-blind phase, all participants received open-label niacin for the next six months. All patients were evaluated at baseline, six months, and one year of treatment. The main outcome measure was the Unified Parkinson's Disease Rating Scale III (UPDRS III) scores. Secondary outcome measures were depression, sleep quality, mental flexibility and cognition, and physical fatigue. Results Niacin treatment was tolerated well by 45 subjects. The baseline mean UPDRS III score was 21.3 ± 15.8 for the niacin group and 22.4 ± 11.8 for placebo. The change with six months of placebo was 1.5 [95% CI, -0.73 to 3.73], and niacin was − 1.06 [95% CI, -3.68 to 1.57]. From six to twelve months, the average UPDRS III score decreased for the placebo group by 2.66 [95% CI, -0.95 to 6.24] and the niacin group by 4.63 [95% CI, 1.42 to 7.83]. Eight subjects withdrew from the study before the 6-month time point and eight more before the one-year time point due to voluntary discontinuation, flushing, or inability to continue (SARS-CoV-2 shut-down). Conclusion Low-dose niacin supplementation may be helpful as an adjunct therapy in improving motor function in PD. Trial registration: Clinicaltrials.gov, NCT03462680. Registered 12 March 2018- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03462680?term=gpr109A&draw=2&rank=1

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