Navegando por Autor "Roy, Daniel"

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Endovascular thrombectomy and medical therapy versus medical therapy alone in acute stroke: a randomized care trial”
(2017-09) Khoury, Naim N.; Darsaut, Tim E.; Ghostine, Jimmy; Deschaintre, Yan; Daneault, Nicole; Durocher, André; Lanthier, Sylvain; Poppe, Alexandre Y.; Odier, Céline; Lebrun, Louise-Hélène; Guilbert, François; Gentric, Jean-Christophe; Batista, André Lima; Weill, Alain; Roy, Daniel; Bracard, Serge; Raymond, Jean
Background. – Until recently, the benefits of endovascular treatment in stroke were not proven. Care trials have been designed to simultaneously offer yet-to-be validated interventions and verify treatment outcomes. Our aim was to implement a care trial for patients with acute ischemic stroke. Methods. – The study was offered to all patients considered for endovascular management of acute ischemic stroke in one Canadian hospital. Inclusion criteria were broad: onset of symptoms ≤ 5 h or at any time in the presence of clinical-imaging mismatch and suspected or demonstrated proximal large vessel occlusion. Exclusion criteria were few: established infarction or hemorrhagic transforma tion of the target symptomatic territory and poor 3-month prognosis. The primary outcome was mRS ≤ 2 at 3 months. Patients were randomly allocated to standard care or standard care plus endovascular treatment. ClinicalTrials.gov: Identifier NCT02157532. Results. – Seventy-seven patients were recruited in 19 months (March 2013–October 2014) at a single center. Randomized allocation was interrupted when other trials showed the benefits of endovascular therapy. At 3 months, 20 of 40 patients (50.0%; 95% CI: 35%–65%) in the intervention group had reached the primary outcome, compared to 14 of 37 patients (37.8%; 95% CI: 24%–54%) in the control group (P = 0.36). Eleven patients in the intervention group died within 3 months compared to 9 patients in the standard care group. Conclusion. – A care trial was implemented to offer verifiable care to acute stroke patients. This approach offers a promising means to manage clinical dilemmas and guide uncertain practices.
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, Jean
BackgroundEndovascular 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.
Le traitement des MAVS cérébrales (TOBAS): une étude randomisée controlée avec registre
(Elsevier, 2016) Magro, Elsa; Gentric, Jean-Christophe; Darsaut, T.E.; Batista, André Lima; Chaalala, Chiraz; Roberge, D.; Weill, Alain; Roy, Daniel; Bojanowski, Michel Wieslaw; Raymond, Jean
Objective. – The management of unruptured and ruptured brain arteriovenous malformations (AVMs) remains controversial. The Treatment of Brain AVM Study (TOBAS) was designed to assess curative treat ments in the management of AVMs. The purpose of our study is to provide a care trial context to brain AVM patients. Methods. – TOBAS is a pragmatic, prospective study including 2 randomized controlled trials and a regis try.AllAVMpatients can be recruited. The preferredmanagementmodality will be predetermined prior to randomization by the team based on clinical judgment. Patients eligible for both conservative and inter ventional management will be randomly allocated conservative or curative treatment. Randomization will be stratified by a treatment modality (surgery, radiosurgery or embolization) and minimized accor ding to a history of previous rupture and Spetzler-Martin grade. A second randomization will allocate eligible patients to embolization/no embolization prior to surgery or radiosurgery. The primary outcome of the study is death (any cause) or disabling stroke (mRS > 2) at 10 years. All patients managed according to clinical judgment alone will be included in the registry. The study is registered under: wwwTrials.gov, ID: NCT02098252. Expected results. – A minimum recruitment of 540 patients is required to show that treatment can reduce the primary outcome by 10 % (from 25 to 15 %); 440 patients will be needed to show a 10 % increase in angiographic occlusion for a good clinical outcome with pre-embolization. Conclusion. – The trial is designed to offer optimal and verifiable care to patients with brain AVMs in spite of the uncertainty. We are currently seeking the participation of multiple centers.
Radiculo-pial spinal arteriovenous fistulas treated with coils: report of two cases
(Interventional Neuroradiology, 2015-06-25) Batista, André Lima; Romero, Diego Gutierrez; Gentric, Jean-Christophe; Weill, Alain; Raymond, Jean; Roy, Daniel
Spinal pial arteriovenous fistulas (SPAVFs) are rare lesions that present more frequently in young patients. Lesions located on radiculo-pial arteries without involvement of the anterior spinal artery are even rarer. SPAVFs may present with mass effect, venous congestion or hemorrhage. Most often, treatment is performed either by surgery or endovascularly with fluid embolic material. Use of microcoils has not been reported for this condition. We present two cases of radiculo-pial high-flow SPAVFs in two patients in their early 30 s. One patient presented with abrupt headache without proof of hemorrhage and the other one with trigeminal neuralgia resulting from dilated posterior fossa draining veins remote from the fistula. Both patients were successfully treated with endovascular shunt closure using microcoils with resolution of symptoms and disappearance of the dilated veins at follow-up. With recent advances in microcatheter technology, distal navigation and microcoil embolization offers another option for these cases that may be safer than fluid embolic material.
Ruptured isolated spinal artery aneurysms report of two cases and review of the literature
(Interventional Neuroradiology, 2014-01-01) Romero, Diego Gutierrez; Batista, Andre Lima; Gentric, Jean Christoph; Raymond, Jean; Roy, Daniel; Weill, Alain
Isolated spinal artery aneurysms are exceedingly rare vascular lesions thought to be related to dissection of the arterial wall. We describe two cases presenting with spinal subarachnoid haemorrhage that underwent conservative management. In the first patient the radiculomedullary branch involved was feeding the anterior spinal artery at the level of D3 and thus, neither endovascular nor surgical approach was employed. Control angiography was performed at seven days and at three months, demonstrating complete resolution of the lesion. In our second case, neither the anterior spinal artery or the artery of Adamkiewicz could be identified during angiography, thus endovascular management was deemed contraindicated. Magnetic resonance imaging showed a stable lesion in the second patient. No rebleeding or other complications were seen. In comparison to intracranial aneurysms, spinal artery aneurysms tend to display a fusiform appearance and lack a clear neck in relation to the likely dissecting nature of the lesions. Due to the small number of cases reported, the natural history of these lesions is not well known making it difficult to establish the optimal treatment approach. Various management strategies may be supported, including surgical and endovascular treatment, but It would seem that a wait and see approach is also viable, with control angiogram and treatment decisions based on the evolution of the lesion.
Safety of Abciximab injection during endovascular treatment of ruptured aneurysms
(Interventional Neuroradiology, 2015-05) Gentric, Jean-Christophe; Brisson, Joelle; Batista, André Lima; Ghostine, Jimmy; Raymond, Jean; Roy, Daniel; Weill, Alain
Background and purpose: We aimed to determine the safety of intra-arterial Abciximab injection in the management of thromboembolic complications during endovascular treatment of ruptured cerebral aneurysms. Methods: In a monocentric consecutive series of endovascular treatment of 783 ruptured aneurysms, 42 (5.3%) patients received Abciximab after the aneurysm was secured. Bleeding complications were registered and dichotomized as follows: new intracranial hemorrhage and peripheral bleeding. For each patient, World Federation of Neurosurgery (WFNS) sub arachnoid hemorrhage (SAH) grade, shunting, and clinical outcomes in the post-operative period and at 3–6 months were recorded. Results: SAH WFNS grades were as follows: grade I n ¼ 14, grade II n ¼ 10, grade III n ¼ 11, grade IV n ¼ 4, grade V n ¼ 3. Ten patients had intracranial hematoma additionally to the SAH prior to embolization. Four patients (9.5%) presented more blood on the post-embolization CT but only one suffered a new clinically relevant intracranial hemorrhage. Two patients (4.8%) experienced significant peripheral bleeding but none were associated with long-term disabilities. Fourteen patients had a shunt installed less than 24 h prior to Abciximab injection and one less than 48 h later. At 3–6-month follow-up, 31 patients (74%) achieved a modified Rankin Scale score (mRS) of 2 or less, six patients (14%) had a mRS of 3–5, three were dead (7%), and two were lost at follow-up. Conclusion: When the aneurysm is secured, intra-arterial Abciximab injection is a low complication rate treatment modality for thromboembolic events during embolization of cerebral ruptured aneurysm
The Treatment of Brain Arteriovenous Malformation Study (TOBAS): a preliminary inter-and intra-rater agreement study on patient management
(Elsevier, 2017-07) Fahed, Robert; Batista, André Lima; Darsaut, Tim E.; Gentric, Jean-Christophe; Ducroux, Célina; Chaalala, Chiraz; Roberge, David; Bojanowski, Michel W.; Weill, Alain; Roy, Daniel; Magro, Elsa; Raymond, Jean
Object. – The best management of brain arteriovenous malformation (bAVM) patients remains unknown. Randomized allocation may be more readily accepted when there is uncertainty and disagreement regarding the management of potential participants. In planning for a trial, we aimed to assess variability and agreement among physicians managing bAVM patients. Methods. – A portfolio composed of 35 patients was sent to 47 clinicians of various specialties managing bAVM patients. For each patient, physicians were asked their best management deci sion (surgery/embolization/radiosurgery/conservative), their confidence level, and whether they would include the patientin a randomized trial comparing conservative and curative management. Seven physi cians, who had access to all images of each patient, independently responded twice, to assess inter and intra-rater agreement using kappa statistics. Results. – The inter-rater agreement (30 raters, including 16 neuroradiologists) for best management decision was only “fair” ( [95%CI] = 0.210[0.157; 0.295]). Agreement remained below ‘substantial’( < .6) between physicians of the same specialty, and when no distinctions were made between various treat ments (when responses were dichotomized as conservative versus curative). With access to all images the inter-rater agreement remained fair. The intra-rater agreement reached “substantial” only for the dichotomized decisions. Responding clinicians were willing to include 54.4% of patients (mainly unrup tured bAVMs) in a randomized trial. Conclusion. – There is a lack of agreement among clinicians involved in the management of bAVM patients. In this study a substantial proportion of clinicians were willing to offer randomized allocation of man agement options to a substantial number of patients.
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, Jean
OBJECTIVE 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).
Treatment of Brain AVMs (TOBAS): study protocol for a pragmatic randomized controlled trial
(Trials (London), 2015-11-04) Darsaut, Tim E.; Magro, Elsa; Gentric, Jean-Christophe; Batista, André Lima; Chaalala, Chiraz; Roberge, David; Bojanowski, Michel W.; Weill, Alain; Roy, Daniel; Raymond, Jean
Background: The management of unruptured brain arteriovenous malformation (AVM) patients remains controversial. Furthermore, curative attempts to treat ruptured AVM patients have not been questioned so far, and there is a lack of prospective data on clinical results according to treatment modality. Endovascular treatment is often used aiming to improve the safety or efficacy of surgery or radiation therapy, but benefits have never been documented in a trial. A care trial context is needed to evaluate interventions at the same time they are practised. Methods/Trial design: TOBAS is a pragmatic, prospective, multicenter, randomized, controlled trial and registry which offers a care trial context for brain AVM patients, including surgical resection, radiosurgery or endovascular embolization, alone or combined. The study includes two RCTs and a multimodality prospective registry. The objectives of the proposed study are to assess whether preventive interventions (surgery, embolization, radiation therapy, alone or combined), selected by the local treatment team and performed as locally practiced, randomly allocated and compared with conservative management, in unruptured brain AVM patients eligible for active or conservative management, can improve the proportion of patients having an independent outcome (modified Rankin Scale (mRS) < 3, as assessed by a standardized questionnaire administered by non-masked care personnel) at 10 years. All patients judged ineligible for randomized allocation are to be entered in a multimodal registry. The objective of a nested trial in patients with ruptured or unruptured AVMs to be treated by surgery or radiation therapy, is to assess whether pre-surgical or pre-radiation embolization, randomly allocated and compared with no embolization, can improve the proportion of patients with complete eradication of the AVM, as locally adjudicated, combined with a good clinical outcome (mRS < 3). The study will require up to 2000 patients in approximately 30 centers or more, followed for 10 years. TOBAS is registered at clinicaltrials.gov: NCT02098252 as of 25 March 2014.

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Navegando por Autor "Roy, Daniel"