Intracranial Aneurysm Clinical Trial
— APPLYOfficial title:
APPLY Study: A Prospective, Single Center Study Appraising the Embolization of Aneurysms Using the Balt Optima™ Coil System
In recent years, many developments have been made to the tools and techniques used to treat IAs via endovascular intervention. Specifically, to the detachable coils themselves. In March 2018, the US Food and Drug administration granted Balt USA 510(k) clearance for the Optima Coil System™. Earlier this year, the list of devices included within the system has expanded to include OptiMAX Complex Super Soft and Complex Soft coils. It consists of coils that come in Standard, Soft and Super Soft profiles and allows for instant detachment from the pusher. The APPLY study is a prospective, single-center investigator-initiated study meant to assess the use of the Balt Optima™ Coil System. The site is looking to enroll approximately 30 subjects over the course of two years. The Optima Coil System™ is commercially available in the United States as such this study is looking for real-world data.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | April 9, 2023 |
Est. primary completion date | April 9, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients age = 18 - Patients undergoing the embolization of large or small intracranial aneurysms - Patient's physician has decided that the best treatment for the patient's neurovascular abnormalities is the Optima Coil System and the patient has agreed to the treatment - Of the total number of coils implanted Optima™ Coil System accounts for at least 80% - Fully executed IRB approved Informed Consent Exclusion Criteria: - Patient participation in another study that may disrupt the results of this study - Anticipated life expectancy of less than 12-months |
Country | Name | City | State |
---|---|---|---|
United States | Vascular Neurology of Southern California | Thousand Oaks | California |
Lead Sponsor | Collaborator |
---|---|
Vascular Neurology of Southern California Inc. |
United States,
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. — View Citation
Brilstra EH, Rinkel GJ, van der Graaf Y, van Rooij WJ, Algra A. Treatment of intracranial aneurysms by embolization with coils: a systematic review. Stroke. 1999 Feb;30(2):470-6. Review. — View Citation
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. — View Citation
Guglielmi G. History of endovascular endosaccular occlusion of brain aneurysms: 1965-1990. Interv Neuroradiol. 2007 Sep;13(3):217-24. Epub 2007 Sep 15. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Mascitelli JR, Moyle H, Oermann EK, Polykarpou MF, Patel AA, Doshi AH, Gologorsky Y, Bederson JB, Patel AB. An update to the Raymond-Roy Occlusion Classification of intracranial aneurysms treated with coil embolization. J Neurointerv Surg. 2015 Jul;7(7):496-502. doi: 10.1136/neurintsurg-2014-011258. Epub 2014 Jun 4. — View Citation
Molyneux AJ, Kerr RS, Yu LM, Clarke M, Sneade M, Yarnold JA, Sandercock P; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion. Lancet. 2005 Sep 3-9;366(9488):809-17. — View Citation
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. — View Citation
van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988 May;19(5):604-7. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occlusion Rates | Successful occlusion rates defined as Raymond-Roy Occlusion Class I and II. | 12 Months | |
Primary | Mortality | All-cause mortality. | 12 Months | |
Secondary | Occlusion Scale Score | Raymond-Roy Occlusion classification is measured via angiographic imaging of endovascularly treated intracranial aneurysms. The classes are the following: Class I indicates complete obliteration of the aneurysm. Class II indicates that post-coiling some residual neck is left. Class IIIa indicates residual aneurysm remains after coiling but these are likely to improve to Class I or II over time. Class IIIb indicates residual aneurysm remains but these are wider and larger, they also have a higher retreatment rate. Ideal aneurysm coiling classification post procedure is Class I, Class II, and in some cases Class IIIa. | Immediately post-procedure, 3-Months, and 12-Months | |
Secondary | Modified Rankin Scale (mRS) | Good Clinical Outcome defined as mRS = 0 - 2. The modified Rankin Scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other neurological disability via interview of subject or family. The scale ranges from 0 to 6, with 0 being the best outcome and 6 being the worst. Score 0 = patient shows no symptoms. Score 1 = no significant disability despite some symptoms, but patient is able to carry out all usual duties/activities. Score 2 = slight disability, patient is unable to carry out all previous activities but is able to look after their own affairs. Score 3 = moderate disability, requiring some help, but able to walk without assistance. Score 4 = moderate severe disability, patient is unable to walk and/or attend to their own bodily needs. Score 5 = severe disability, patient is bedridden, incontinent and requires constant nursing care. Score 6 = patient has expired. | Up to 1 year during various scheduled visits. Specifically, at discharge from hospital, at 3-month follow up and again at 12-months. | |
Secondary | Packing Density | Number of coils necessary for packing density | Result is known immediately post-procedure. | |
Secondary | Fluro Time | Fluro time per case. | Result is known immediately post-procedure. | |
Secondary | Other Devices Used | Use of adjuncts, stent/balloon/Comaneci | Result is known immediately post-procedure. | |
Secondary | Complications | Major complications (i.e. intraoperative complications: inadvertent coil detachment, rupture/re-rupture, retreatment) | At all time points from procedure to 12 Months. | |
Secondary | SAE | Serious Adverse Events post-procedure at discharge, 3-months, and through the final 12-month visit-device related or otherwise. | At all time points from procedure to 12 Months. | |
Secondary | Thromboembolic Events | Post-treatment major thromboembolic events are defined as stroke events that occur immediately after the index procedure. Post endovascular coiling subjects are often at risk for stroke, this occurs as a formation in the blood vessel of a clot breaks loose and is carried by the blood stream and occludes another vessel. Thromboembolic events represent one of the most serious complications of embolization therapy, due to the possibility of permanent neurologic disability and death. As such these events will be closely monitored. This is not a quantitative or qualitative measurement but rather an archive of the circumstances should an event occur. | At all time points from procedure to 12 Months. |
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