Appraising the Embolization of Aneurysms Using Balt Optima™ Coil System (APPLY Study) (APPLY)
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|ClinicalTrials.gov Identifier: NCT04499508|
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : August 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Aneurysm Intracranial Aneurysm Ruptured Aneurysm Subarachnoid Hemorrhage, Aneurysmal Cerebral Aneurysm Unruptured||Device: Optima Coil System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a prospective, single-arm, single-center, post-market, real-world, investigator-initiated study.|
|Masking:||None (Open Label)|
|Official Title:||APPLY Study: A Prospective, Single Center Study Appraising the Embolization of Aneurysms Using the Balt Optima™ Coil System|
|Actual Study Start Date :||April 10, 2020|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2022|
Experimental: Treatment with Optima Balt Coils
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
Patients who have qualified for endovascular coiling in effort to treat intracranial aneurysms were treated with
- Occlusion Rates [ Time Frame: 12 Months ]Successful occlusion rates defined as Raymond-Roy Occlusion Class I and II.
- Mortality [ Time Frame: 12 Months ]All-cause mortality.
- Occlusion Scale Score [ Time Frame: Immediately post-procedure, 3-Months, and 12-Months ]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.
- Modified Rankin Scale (mRS) [ Time Frame: Up to 1 year during various scheduled visits. Specifically, at discharge from hospital, at 3-month follow up and again at 12-months. ]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.
- Packing Density [ Time Frame: Result is known immediately post-procedure. ]Number of coils necessary for packing density
- Fluro Time [ Time Frame: Result is known immediately post-procedure. ]Fluro time per case.
- Other Devices Used [ Time Frame: Result is known immediately post-procedure. ]Use of adjuncts, stent/balloon/Comaneci
- Complications [ Time Frame: At all time points from procedure to 12 Months. ]Major complications (i.e. intraoperative complications: inadvertent coil detachment, rupture/re-rupture, retreatment)
- SAE [ Time Frame: At all time points from procedure to 12 Months. ]Serious Adverse Events post-procedure at discharge, 3-months, and through the final 12-month visit-device related or otherwise.
- Thromboembolic Events [ Time Frame: At all time points from procedure to 12 Months. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04499508
|Contact: Anastasia Vechera, BA||805-242-4884 ext firstname.lastname@example.org|
|Contact: Muhammad A Taqi, MD||805-242-4884 ext email@example.com|
|United States, California|
|Vascular Neurology of Southern California||Recruiting|
|Thousand Oaks, California, United States, 91360|
|Contact: Muhammad A Taqi, MD 805-242-4884 ext 4 firstname.lastname@example.org|
|Contact: Anastasia Vechera, BA 805-242-4884 ext 2 email@example.com|
|Principal Investigator: Muhammad A Taqi, MD|
|Principal Investigator:||Muhammad A Taqi, MD||Vascular Neurology of Southern California|
|Study Director:||Anastasia Vechera, BA||Vascular Neurology of Southern California|