Appraising the Embolization of Aneurysms Using Balt Optima™ Coil System (APPLY Study)

NCT04499508 | Unknown DMC FDA Device

• 1 other identifier: VNSC-022020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aneurysm; Intracranial Aneurysm; Ruptured Aneurysm; Subarachnoid Hemorrhage, Aneurysmal; Cerebral Aneurysm Unruptured

Keywords

Brain aneurysm; Optima Coil System; Endovascular Coiling; Embolization; Ruptured Intracranial Aneurysm; Unruptured Intracranial Aneurysm

Outcome Measures

Primary Outcomes (2)

• Occlusion Rates

  Successful occlusion rates defined as Raymond-Roy Occlusion Class I and II.

  12 Months

• Mortality

  All-cause mortality.

  12 Months

Secondary Outcomes (8)

• Occlusion Scale Score

  Immediately post-procedure, 3-Months, and 12-Months

• Modified Rankin Scale (mRS)

  Up to 1 year during various scheduled visits. Specifically, at discharge from hospital, at 3-month follow up and again at 12-months.

• Packing Density

  Result is known immediately post-procedure.

• Fluro Time

  Result is known immediately post-procedure.

• Other Devices Used

  Result is known immediately post-procedure.

Study Arms (1)

Treatment with Optima Balt Coils

EXPERIMENTAL

The APPLY study is a single-arm prospective study which means that everyone enrolled in the clinical trial will be/has been treated with the Optima Balt Coils.

Device: Optima Coil System

Interventions

Optima Coil System DEVICE

Patients who have qualified for endovascular coiling in effort to treat intracranial aneurysms were treated with

Also known as: Embolization of Intracranial Aneurysm, Optima Balt Coil System, Neurovascular Embolization Device

Treatment with Optima Balt Coils

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient participation in another study that may disrupt the results of this study
• Anticipated life expectancy of less than 12-months

Sponsors & Collaborators

• Vascular Neurology of Southern California Inc.: lead

Study Sites (1)

Vascular Neurology of Southern California

Thousand Oaks, California, 91360, United States

RECRUITING

Related Publications (12)

• 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. doi: 10.1016/S0140-6736(05)67214-5.

  PMID: 16139655 BACKGROUND

• 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.

  PMID: 19193745 BACKGROUND

• 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. doi: 10.1227/01.NEU.0000255335.72662.25.

  PMID: 17327787 BACKGROUND

• 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.

  PMID: 26251248 BACKGROUND

• Guglielmi G. History of endovascular endosaccular occlusion of brain aneurysms: 1965-1990. Interv Neuroradiol. 2007 Sep;13(3):217-24. doi: 10.1177/159101990701300301. Epub 2007 Sep 15.

  PMID: 20566113 BACKGROUND

• 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.

  PMID: 17032854 BACKGROUND

• 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.

  PMID: 12006273 BACKGROUND

• 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.

  PMID: 26047409 BACKGROUND

• 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.

  PMID: 24898735 BACKGROUND

• 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. doi: 10.3171/jns.1968.28.1.0014. No abstract available.

  PMID: 5635959 BACKGROUND

• 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. doi: 10.1161/01.str.19.5.604.

  PMID: 3363593 BACKGROUND

• 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. doi: 10.1161/01.str.30.2.470.

  PMID: 9933290 RESULT

MeSH Terms

Conditions

Aneurysm; Intracranial Aneurysm; Aneurysm, Ruptured; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Muhammad A Taqi, MD

  Vascular Neurology of Southern California

  PRINCIPAL INVESTIGATOR

• Anastasia Vechera, BA

  Vascular Neurology of Southern California

  STUDY DIRECTOR

Central Study Contacts

Anastasia Vechera, BA

CONTACT

805-242-4884; avechera@vnsc.org

Muhammad A Taqi, MD

CONTACT

805-242-4884; asiftaqi@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-arm, single-center, post-market, real-world, investigator-initiated study.

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 5, 2020
• Study Start: April 10, 2020
• Primary Completion: April 9, 2023
• Study Completion: April 9, 2023
• Last Updated: April 26, 2022

Record last verified: 2022-04

Locations

US (1)