دورية أكاديمية
أعرض في EDS

New generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): a study protocol for a multicenter randomized controlled trial.

التفاصيل البيبلوغرافية
العنوان: New generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): a study protocol for a multicenter randomized controlled trial.
المؤلفون: Abi-Aad KR; Department of Neurological Surgery, Mayo Clinic, 5777 E Mayo Boulevard, Phoenix, AZ, 85054, USA., Aoun RJN; Department of General Surgery, Cleveland Clinic, Cleveland, OH, USA., Rahme RJ; Department of Neurological Surgery, Northwestern University, Chicago, IL, USA., Ward JD; Department of Neurological Surgery, Northwestern University, Chicago, IL, USA., Kniss J; Department of Neurological Surgery, Northwestern University, Chicago, IL, USA., Kwasny MJ; Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA., Sattur MG; Department of Neurological Surgery, Mayo Clinic, 5777 E Mayo Boulevard, Phoenix, AZ, 85054, USA., Welz ME; Department of Neurological Surgery, Mayo Clinic, 5777 E Mayo Boulevard, Phoenix, AZ, 85054, USA., Bendok BR; Department of Neurological Surgery, Mayo Clinic, 5777 E Mayo Boulevard, Phoenix, AZ, 85054, USA. bendok.bernard@mayo.edu.
المصدر: Neuroradiology [Neuroradiology] 2018 Oct; Vol. 60 (10), pp. 1075-1084. Date of Electronic Publication: 2018 Aug 17.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Springer-Verlag Country of Publication: Germany NLM ID: 1302751 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-1920 (Electronic) Linking ISSN: 00283940 NLM ISO Abbreviation: Neuroradiology Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Berlin, New York, Springer-Verlag.
مواضيع طبية MeSH: Research Design*, Endovascular Procedures/*instrumentation , Hydrogels/*therapeutic use , Intracranial Aneurysm/*therapy, Adolescent ; Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Multicenter Studies as Topic ; Platinum ; Randomized Controlled Trials as Topic ; Recurrence
مستخلص: 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.
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فهرسة مساهمة: Keywords: Bare platinum coil; Endovascular coils; Hydrogel coil; Intracranial aneurysms; Subarachnoid hemorrhage
المشرفين على المادة: 0 (Hydrogels)
49DFR088MY (Platinum)
تواريخ الأحداث: Date Created: 20180819 Date Completed: 20181211 Latest Revision: 20181211
رمز التحديث: 20240628
DOI: 10.1007/s00234-018-2074-5
PMID: 30120516
قاعدة البيانات: MEDLINE
الوصف
تدمد:1432-1920
DOI:10.1007/s00234-018-2074-5