Trial reportNeuroradiology2016
GREAT-a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results.
Trial report in Neuroradiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Outcomes Associated With Intracranial Aneurysm Treatments Reported as Safe, Effective, or Durable: A Systematic Review and Meta-Analysis.JAMA network open · 2023Pooled it
- Clinical outcomes of first- and second-generation hydrogel coils compared with bare platinum coils: a systematic literature review.Neurosurgical review · 2022Pooled it
- Hydrogel coils versus bare platinum coils for the endovascular treatment of intracranial aneurysms: a meta-analysis of randomized controlled trials.BMC neurology · 2018Pooled it
- Trial
- Article
- Safety and Efficacy of Prestige Coils for Embolization of Vascular Abnormalities: The Embo-Prestige Study.Journal of personalized medicine · 2023Article
- Comparison between second generation HydroSoft coils and bare platinum coils for the treatment of large intracranial aneurysms.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2023Article
- Predictors of the Effects of Flow Diversion in Very Large and Giant Aneurysms.AJNR. American journal of neuroradiology · 2021Article
- Flow diverter-coil technique for endovascular treatment of complex wide neck brain aneurysms, Technical point.Caspian journal of internal medicine · 2021Article
- The SMART Registry: Long-Term Results on the Utility of the Penumbra SMART COIL System for Treatment of Intracranial Aneurysms and Other Malformations.Frontiers in neurology · 2021Article
- Advances in endovascular aneurysm management: flow modulation techniques with braided mesh devices.Stroke and vascular neurology · 2020Review
- Histological and Transmission Electron Microscopy Results after Embolization with HydroSoft/HydroFrame Coils in Experimental Swine Aneurysm.BioMed research international · 2019Article
- Endovascular Therapy for a Post-irradiated Cervical Pseudoaneurysm at the Carotid Stump: A Case Report.NMC case report journal · 2017Article
- Cerebral aneurysm treatment: modern neurovascular techniques.Stroke and vascular neurology · 2016Review
- A call for neurologists to take up stroke intervention.Annals of Indian Academy of NeurologyReview
- Comparison of hydrogel coils versus bare platinum coils for the treatment of anterior communicating artery aneurysms.Brain circulationArticle
- Safety/Efficacy of a Pusher, Thermal Detachment Coil for Ruptured Intracranial Aneurysms: A Multicenter Real-World Study.Journal of neuroimaging : official journal of the American Society of NeuroimagingArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionHybrid hydrogel-platinum coils (HydroCoil) have proven effective for endovascular aneurysm treatment. To overcome technical limitations (coil stiffness, time restriction for placement), a second generation of softer hydrogel coils has been brought to clinical practice (HydroSoft, HydroFrame). We report on procedural safety and core-lab-assessed angiographic results from an open-label multicenter randomized controlled trial.
methodsWeb-based randomization occurred in 15 medical centers in France and seven in Germany between coil embolization with second-generation hydrogel coils and treatment with any bare platinum coil. Assist devices could be used as clinically required. Primary endpoint is a composite outcome including major aneurysm recurrence and poor clinical outcome at 18 months follow-up.
resultsFive hundred thirteen patients were randomized (hydrogel n = 256, bare platinum n = 257). Twenty patients were excluded for missing informed consent and nine patients for treatment related criteria. Four hundred eighty-four patients were analyzed as randomized (hydrogel n = 243, bare platinum n = 241). Two hundred eight had ruptured aneurysms (43 %). Prespecified procedural complications occurred in 58 subjects (hydrogel n = 28, bare platinum n = 30, p = 0.77). The 14-day mortality rate was 2.1 % in both arms of the study. The median calculated packing densities for aneurysms assigned to hydrogel and bare platinum were 39 and 31 % respectively (p < 0.001). No statistically significant differences were found between arms in the post procedural angiographic occlusion rate (p = 0.8).
conclusionSecond-generation hydrogel coils can be used in a wide spectrum of aneurysms with a risk profile equivalent to bare platinum. Packing density was significantly higher in aneurysms treated with hydrogel coils.
trial registrationhttp://www.germanctr.de , DRKS00003132.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.