Clinical trial NCT04499508: Appraising the Embolization of Aneurysms Using Balt Optima™ Coil System (APPLY Study)
Official title: APPLY Study: A Prospective, Single Center Study Appraising the Embolization of Aneurysms Using the Balt Optima™ Coil System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Vascular Neurology of Southern California Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, single-arm, single-center, post-market, real-world, investigator-initiated study.
Primary purpose: TREATMENT

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.

Detailed description: Intracranial aneurysms both ruptured and unruptured collectively affect a significant portion of the general population. Cases of unruptured intracranial aneurysms (UIA) are estimated to affect roughly 3% of the general population and aneurysmal subarachnoid hemorrhage (aSAH) has an incidence of 8 to 9 people per 100,000. There are two well-established treatment options for patients diagnosed with intracranial aneurysms (IA): surgical clipping and endovascular coiling. Neurosurgical intervention requires a craniotomy followed by the clipping of the aneurysm. Endovascular repair is minimally invasive as access to the afflicted vessel is gained through the femoral artery with the assistance of imaging guidance. During embolization, the aneurysm is occluded using coils of varying length, diameter, and softness. By filling the dome of the aneurysm physicians aim to prevent further blood flow into the bulge which will prevent the aneurysm from rupturing. In addition to coiling a stent may be placed to function as a blood flow diverting device.

The first-ever recorded use of coils in the treatment of intracranial aneurysms by way of endovascular intervention was in 1988. In 1989, detachable coils were designed by Guido Guglielmi, an endovascular neurosurgeon, who pioneered the concept of coil embolization. Since then, endovascular embolization has become effective, and in some cases preferred, method of treatment of intracranial aneurysms. A 2005 randomized, multicenter study titled International Subarachnoid Aneurysm Trial (ISAT) demonstrated that in comparison to surgical clipping, endovascular repair clinical outcomes result in significant risk reduction and long-term independence post-procedure. To verify their findings the ISAT authors reviewed the clinical outcomes at 1 year of 1063 of 1072 patients who underwent ruptured aneurysm embolization using detachable coils compared to 1055 of 1070 who were designated to neurosurgical clipping. At the one-year mark patients who experienced endovascular repair demonstrated poor prognosis with less frequency, as measured by mortality and extent of dependency, in 23.5% of cases in comparison to 30.9% of subjects treated via neurosurgical intervention. While the results seem to show a considerable preference for embolization, the patients in this designated sample were found to experience rebleeds at a higher frequency. Beyond resurgence of hemorrhaging, embolization risks include aneurysm perforation and/or rupture, thromboembolic events, and coil herniation out of the occluded site. Despite the aforementioned risk factors, it has become clear that embolization with detachable coils is a much safer treatment option as the rate of procedure-related complications is relatively low. This is true for patients with unruptured and ruptured intracranial aneurysms-size and location did not show any statistically significant impact.

The study will enroll approximately 30 subjects to allow us to adequately observe the benefits of the central limit theorem. Based on prior experience, we expect that approximately 10% of all participants may be lost to follow-up and/or will withdraw from the study. It is estimated that two years are needed to complete the study. The first year will be necessary to enroll 30 subjects and the second year will be necessary to complete the 12-month follow-up visits and study close out procedures. The device is to be used per Instructions for Use as indicated for treatment of intracranial aneurysms by way of coil embolization. Participating in this study will not contribute or be of detriment in any way of a subject's medical care. All study related data gathering activities are standard of care and do not require any special actions.

Eligibility criteria: 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

Primary outcomes:
measure: Occlusion Rates
timeFrame: 12 Months
measure: Mortality
timeFrame: 12 Months
Secondary outcomes:
measure: Occlusion Scale Score
timeFrame: Immediately post-procedure, 3-Months, and 12-Months
measure: Modified Rankin Scale (mRS)
timeFrame: Up to 1 year during various scheduled visits. Specifically, at discharge from hospital, at 3-month follow up and again at 12-months.
measure: Packing Density
timeFrame: Result is known immediately post-procedure.
measure: Fluro Time
timeFrame: Result is known immediately post-procedure.
measure: Other Devices Used
timeFrame: Result is known immediately post-procedure.
measure: Complications
timeFrame: At all time points from procedure to 12 Months.
measure: SAE
timeFrame: At all time points from procedure to 12 Months.
measure: Thromboembolic Events
timeFrame: At all time points from procedure to 12 Months.
Other outcomes:
Locations:
city: Thousand Oaks
country: United States
facility: Vascular Neurology of Southern California
state: California
Study officials:
affiliation: Vascular Neurology of Southern California
name: Muhammad A Taqi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vascular Neurology of Southern California
name: Anastasia Vechera, BA
role: STUDY_DIRECTOR
References:
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. doi: 10.1016/S0140-6736(05)67214-5.
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