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Endovascular treatment of aneurysms and platinum coil caliber: Study protocol of a randomized, controlled trial.

ABSTRACT: Endovascular 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.The 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.The DELTA trial will test the hypothesis that the use of coils of larger caliber can improve angiographic results of endovascular coiling.

SUBMITTER: Ghostine J

PROVIDER: S-EPMC5564365 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Endovascular treatment of aneurysms and platinum coil caliber: Study protocol of a randomized, controlled trial.

Ghostine Jimmy J Khoury Naim N Cloutier Francis F Kotowski Marc M Gentric Jean-Christophe JC Batista André L AL Weill Alain A Roy Daniel D Darsaut Tim E TE Raymond Jean J

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences 20160816 6

<h4>Background</h4>Endovascular 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.<h4>Methods</h4>The Does Embolization with Larger coils lead to better Treatment of Aneurysms ...[more]

PMID: 27530135

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Project description:Background and purposeThe ability of polymer-modified coils to promote stable aneurysm occlusion after endovascular treatment is not well-documented. Angiographic aneurysm recurrence is widely used as a surrogate for treatment failure, but studies documenting the correlation of angiographic recurrence with clinical failure are limited. This trial compares the effectiveness of Matrix(2) polyglycolic/polylactic acid biopolymer-modified coils with bare metal coils and correlates the angiographic findings with clinical failure (ie, target aneurysm recurrence), a composite end point that includes any incident of posttreatment aneurysm rupture, retreatment, or unexplained death.Materials and methodsThis was a multicenter randomized noninferiority trial with blinded end point adjudication. We enrolled 626 patients, divided between Matrix(2) and bare metal coil groups. The primary outcome was target aneurysm recurrence at 12 ± 3 months.ResultsAt 455 days, at least 1 target aneurysm recurrence event had occurred in 14.6% of patients treated with bare metal coils and 13.3% of Matrix(2) (P = .76, log-rank test) patients; 92.8% of target aneurysm recurrence events were re-interventions for aneurysms that had not bled after treatment, and 5.8% of target aneurysm recurrence events resulted from hemorrhage or rehemorrhage, with or without retreatment. Symptomatic re-intervention occurred in only 4 (0.6%) patients. At 455 days, 95.8% of patients with unruptured aneurysms and 90.4% of those with ruptured aneurysms were independent (mRS ≤ 2). Target aneurysm recurrence was associated with incomplete initial angiographic aneurysm obliteration, presentation with rupture, and a larger aneurysmal dome and neck size.ConclusionsTested Matrix(2) coils were not inferior to bare metal coils. Endovascular coiling of intracranial aneurysms was safe, and the rate of technical success was high. Target aneurysm recurrence is a promising clinical outcome measure that correlates well with established angiographic measurements.

Project description:BackgroundEndovascular therapy (EVT) for acute ischemic stroke due to proximal occlusion of the anterior intracranial circulation, started within 6 h from symptom onset, has been proven safe and effective. Recently, EVT has been proven effective beyond the 6-h time window in a highly selected population using CT perfusion or MR diffusion. Unfortunately, these imaging modalities are not available in every hospital, and strict selection criteria might exclude patients who could still benefit from EVT. The presence of collaterals on CT angiography (CTA) may offer a more pragmatic imaging criterion that predicts possible benefit from EVT beyond 6 h from time last known well. The aim of this study is to assess the safety and efficacy of EVT for patients treated between 6 and 24 h from time last known well after selection based on the presence of collateral flow.MethodsThe MR CLEAN-LATE trial is a multicenter, randomized, open-label, blinded endpoint trial, aiming to enroll 500 patients. We will investigate the efficacy of EVT between 6 and 24 h from time last known well in acute ischemic stroke due to a proximal intracranial anterior circulation occlusion confirmed by CTA or MRA. Patients with any collateral flow (poor, moderate, or good collaterals) on CTA will be included. The inclusion of poor collateral status will be restricted to a maximum of 100 patients. In line with the current Dutch guidelines, patients who fulfill the characteristics of included patients in DAWN and DEFUSE 3 will be excluded as they are eligible for EVT as standard care. The primary endpoint is functional outcome at 90 days, assessed with the modified Rankin Scale (mRS) score. Treatment effect will be estimated with ordinal logistic regression (shift analysis) on the mRS at 90 days. Secondary endpoints include clinical stroke severity at 24 h and 5-7 days assessed by the NIHSS, symptomatic intracranial hemorrhage, recanalization at 24 h, follow-up infarct size, and mortality at 90 days, DISCUSSION: This study will provide insight into whether EVT is safe and effective for patients treated between 6 and 24 h from time last known well after selection based on the presence of collateral flow on CTA.Trial registrationNL58246.078.17 , ISRCTN19922220 , Registered on 11 December 2017.

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Endovascular treatment of aneurysms and platinum coil caliber: Study protocol of a randomized, controlled trial.

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Endovascular treatment of aneurysms and platinum coil caliber: Study protocol of a randomized, controlled trial.

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