Intracranial Aneurysm — Appraising the Embolization of Aneurysms Using Balt Optima™ Coil System (APPLY Study)
Citation(s)
Ayling OG, Ibrahim GM, Drake B, Torner JC, Macdonald RL Operative complications and differences in outcome after clipping and coiling of ruptured intracranial aneurysms. J Neurosurg. 2015 Sep;123(3):621-8. doi: 10.3171/2014.11.JNS141607. Epub 2015 Jun 5.
Frazer D, Ahuja A, Watkins L, Cipolotti L Coiling versus clipping for the treatment of aneurysmal subarachnoid hemorrhage: a longitudinal investigation into cognitive outcome. Neurosurgery. 2007 Mar;60(3):434-41; discussion 441-2.
Guglielmi G History of endovascular endosaccular occlusion of brain aneurysms: 1965-1990. Interv Neuroradiol. 2007 Sep;13(3):217-24. Epub 2007 Sep 15.
Hunt WE, Hess RM Surgical risk as related to time of intervention in the repair of intracranial aneurysms. J Neurosurg. 1968 Jan;28(1):14-20.
Jalbert JJ, Isaacs AJ, Kamel H, Sedrakyan A Clipping and Coiling of Unruptured Intracranial Aneurysms Among Medicare Beneficiaries, 2000 to 2010. Stroke. 2015 Sep;46(9):2452-7. doi: 10.1161/STROKEAHA.115.009777. Epub 2015 Aug 6.
Katsaridis V, Papagiannaki C, Violaris C Guglielmi detachable coils versus matrix coils: a comparison of the immediate posttreatment results of the embolization of 364 cerebral aneurysms in 307 patients: a single-center, single-surgeon experience. AJNR Am J Neuroradiol. 2006 Oct;27(9):1841-8.
Tamatani S, Ito Y, Abe H, Koike T, Takeuchi S, Tanaka R Evaluation of the stability of aneurysms after embolization using detachable coils: correlation between stability of aneurysms and embolized volume of aneurysms. AJNR Am J Neuroradiol. 2002 May;23(5):762-7.
Yoo E, Kim DJ, Kim DI, Lee JW, Suh SH Bailout stent deployment during coil embolization of intracranial aneurysms. AJNR Am J Neuroradiol. 2009 May;30(5):1028-34. doi: 10.3174/ajnr.A1482. Epub 2009 Feb 4.
APPLY Study: A Prospective, Single Center Study Appraising the Embolization of Aneurysms Using the Balt Optima™ Coil System
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
