Navegando por Autor "Darsaut, Tim E"
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Artigo Endovascular treatment of aneurysms and platinum coil caliber: study protocol of a randomized, controlled trial(American Society of Neuroradiology, 2016-12) Ghostine, Jimmy; Khoury, Naim; Cloutier, Francis; Kotowski, Marc; Gentric, Jean-Christophe; Batista, André Lima; Weill, Alain; Roy, Daniel; Darsaut, Tim E; Raymond, JeanBackgroundEndovascular coil embolization of cerebral aneurysms is an effective treatment for the prevention of aneurysm rebleeding after subarachnoid hemorrhage. It is also often used in unruptured aneurysms, but it is associated with aneurysm remnants and recurrences in up to 20%–33% of patients. We hypothesized that better aneurysm occlusion rates can be achieved with coils of larger caliber. MethodsThe Does Embolization with Larger coils lead to better Treatment of Aneurysms (DELTA) trial is an investigator-initiated, multicenter, prospective, randomized, controlled clinical trial. To test the hypothesis that 15-caliber coiling systems are superior to 10-caliber coils, 564 patients with aneurysms measuring 4–12 mm will be randomized 1:1 to embolization with either 10-caliber coils exclusively (control group) or the highest safely achievable proportion of 15-caliber coils (intervention group). The primary efficacy endpoint of the trial is the occurrence of a major recurrence or a residual aneurysm at one year. A pilot phase of 165 patients will be conducted to verify feasibility of the coiling strategy, compliance to treatment allocation, safety of a 15-caliber platinum coil embolization strategy, recruitment rates, and the capacity to improve packing density. DiscussionThe DELTA trial will test the hypothesis that the use of coils of larger caliber can improve angiographic results of endovascular coiling.Artigo The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research(Journal of neurosurgery, 2018-06) Magro, Elsa; Gentric, Jean-Christophe; Batista, André Lima; Kotowski, Marc; Chaalala, Chiraz; Roberge, David; Weill, Alain; Stapf, Christian; Roy, Daniel; Bojanowski, Michel W; Darsaut, Tim E; Klink, Ruby; Raymond, JeanOBJECTIVE The management of brain arteriovenous malformations (bAVMs) remains controversial. The Treatment of Brain AVMs Study (TOBAS) was designed to manage patients with bAVMs within a clinical research framework. The objective of this study was to study trial feasibility, recruitment rates, patient allocation to the various management groups, and compliance with treatment allocation. METHODS TOBAS combines two randomized care trials (RCTs) and a registry. Designed to be all-inclusive, the study offers randomized allocation of interventional versus conservative management to patients eligible for both options (first RCT), a second RCT testing the role of preembolization as an adjunct to surgery or radiotherapy, and a registry of patients managed using clinical judgment alone. The primary outcome of the first RCT is death from any cause or disabling stroke (modified Rankin Scale score > 2) at 10 years. A pilot phase was initiated at one center to test study feasibility, record the number and characteristics of patients enrolled in the RCTs, and estimate the frequency of crossovers. RESULTS All patients discussed at the multidisciplinary bAVM committee between June 2014 and June 2016 (n = 107) were recruited into the study; 46 in the randomized trials (23 in the first RCT with 21 unruptured bAVMs, 40 in the second RCT with 17 unruptured bAVMs, and 17 in both RCTs), and 61 patients in the registry. Three patients crossed over from surgery to observation (first RCT). CONCLUSIONS Clinical research was successfully integrated with normal practice using TOBAS. Recruitment rates in a single center are encouraging. Whether the trial will provide meaningful results depends on the recruitment of a sufficient number of participating centers. Clinical trial registration no.: NCT02098252 (clinicaltrials.gov).