New generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): a study protocol for a multicenter randomized controlled trial.
Purpose: Aneurysm recanalization constitutes a limitation in the endovascular treatment of intracranial aneurysms using conventional bare platinum coils. The development of platinum coils coupled with hydrogel polymers aimed at decreasing the rates of recurrence by way of enhanced coil packing densi...
| Publicado en: | Neuroradiology Vol. 60; no. 10; pp. 1075 - 1085 |
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| Autores principales: | , , , , , , , , |
| Formato: | pictorial tables/charts Journal Article |
| Publicado: |
Springer Nature
Oct2018
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=131779809&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 131779809 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00283940 NYZ jtl: Neuroradiology issn: 00283940 maglogo: N pubinfo: dt: Oct2018 vid: 60 iid: 10 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 131779809 131779809 131779809 10.1007/s00234-018-2074-5 131779809 ppf: 1075 ppct: 10 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: New generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): a study protocol for a multicenter randomized controlled trial. aug: au: Abi-Aad, Karl R. Aoun, Rami James N. Rahme, Rudy J. Ward, Jennifer D. Kniss, Jason Kwasny, Mary Jeanne Sattur, Mithun G. Welz, Matthew E. Bendok, Bernard R. affil: Department of Neurological Surgery, Mayo Clinic, 5777 E Mayo Boulevard, 85054, Phoenix, AZ, USA sug: subj: Gels Aneurysm Therapy Research Protocols Platinum Treatment Outcomes Random Assignment ab: Purpose: Aneurysm recanalization constitutes a limitation in the endovascular treatment of intracranial aneurysms using conventional bare platinum coils. The development of platinum coils coupled with hydrogel polymers aimed at decreasing the rates of recurrence by way of enhanced coil packing density and biological healing within the aneurysm. While enhanced occlusion and durability has been shown for the first generation hydrogel coils, their use was limited by technical challenges. Less data is available regarding the second-generation hydrogel coils which have been designed to perform like bare platinum coils.Methods: The new generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT) is a multicenter, randomized controlled trial that compares the health outcomes of the second-generation HydroCoil Embolic System with bare platinum coils in the endovascular intracranial aneurysms. The primary endpoint is aneurysm recurrence, defined as any progression on the Raymond aneurysm scale, over a 24-month follow-up period. Secondary endpoints include packing density, functional independence, procedural adverse events, mortality rate, initial complete occlusion, aneurysm retreatment, hemorrhage from treated aneurysm, and any aneurysm recurrence.Results: Patient recruitment initiated in June 2011 and ended in January 2016 in 46 centers. Six hundred eligible patients diagnosed with an intracranial aneurysm, ruptured or unruptured were randomly assigned to one of the two treatment arms.Conclusion: The HEAT trial compares the durability, imaging, and clinical outcomes of the second-generation hydrogel versus bare platinum coils in the endovascular treatment of ruptured or unruptured intracranial aneurysms. The results of this trial may further inform current endovascular treatment guidelines based on observed long-term outcomes. pubtype: Academic Journal doctype: pictorial tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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