AneurysmAPPLYNCT04499508
Appraising the Embolization of Aneurysms Using Balt Optima™ Coil System (APPLY Study)
A study testing Optima Coil System in people with Aneurysm and Intracranial Aneurysm, run by Vascular Neurology of Southern California Inc. at 1 site in United States.
Trial 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™. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm, Intracranial Aneurysm, Ruptured Aneurysm
- What is being tested?
- Optima Coil System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2020to 9 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient participation in another study that may disrupt the results of this study
- Anticipated life expectancy of less than 12-months
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Vascular Neurology of Southern California
Thousand Oaks, California, 91360
Muhammad A Taqi, MD, 805-242-4884 ext. 4, asiftaqi@icloud.com
Anastasia Vechera, BA, 805-242-4884 ext. 2, avechera@vnsc.org
About this study
Official 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.
Read the 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.
- Conditions
- Aneurysm, Intracranial Aneurysm, Ruptured Aneurysm, Subarachnoid Hemorrhage, Aneurysmal, Cerebral Aneurysm Unruptured
- Being tested
- Optima Coil System
- Keywords
- Brain aneurysm, Optima Coil System, Endovascular Coiling, Embolization, Ruptured Intracranial Aneurysm, Unruptured Intracranial Aneurysm
- Medical subject headings
- Aneurysm, Intracranial Aneurysm, Aneurysm, Ruptured, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optima Coil SystemDevice
Also called Embolization of Intracranial Aneurysm, Optima Balt Coil System, Neurovascular Embolization Device
Patients who have qualified for endovascular coiling in effort to treat intracranial aneurysms were treated with
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Optima Coil System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusion Rates
Successful occlusion rates defined as Raymond-Roy Occlusion Class I and II.
Measured: 12 Months
Mortality
All-cause mortality.
Measured: 12 Months
Secondary outcomes (8)
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.
Measured: Immediately post-procedure, 3-Months, and 12-Months
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.
Measured: 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
Number of coils necessary for packing density
Measured: Result is known immediately post-procedure.
Fluro Time
Fluro time per case.
Measured: Result is known immediately post-procedure.
Other Devices Used
Use of adjuncts, stent/balloon/Comaneci
Measured: Result is known immediately post-procedure.
Complications
Major complications (i.e. intraoperative complications: inadvertent coil detachment, rupture/re-rupture, retreatment)
Measured: At all time points from procedure to 12 Months.
SAE
Serious Adverse Events post-procedure at discharge, 3-months, and through the final 12-month visit-device related or otherwise.
Measured: At all time points from procedure to 12 Months.
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.
Measured: At all time points from procedure to 12 Months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start10 Apr 2020
- Primary completion9 Apr 2023 (estimated)
- Study completion9 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm, single-center, post-market, real-world, investigator-initiated study.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vascular Neurology of Southern California Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Muhammad A Taqi, MD, Principal investigator, Vascular Neurology of Southern CaliforniaAnastasia Vechera, BA, Study director, Vascular Neurology of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499508
- Sponsor's protocol ID
- VNSC-022020
- Acronym
- APPLY
- Status last verified
- Apr 2022
- First submitted
- 28 Jul 2020
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 16139655Yoo 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.
PubMed 19193745Frazer 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.
PubMed 17327787Jalbert 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.
PubMed 26251248Guglielmi 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.
PubMed 20566113Katsaridis 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.
PubMed 17032854Tamatani 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.
PubMed 12006273Ayling 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.
PubMed 26047409Mascitelli 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.
PubMed 24898735Hunt 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.
PubMed 5635959van 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.
PubMed 3363593Brilstra 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.
PubMed 9933290
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APPLY Study: A Prospective, Single Center Study Appraising the Embolization of Aneurysms Using the Balt Optima™ Coil System
- ClinicalTrials.gov ID
- NCT04499508
- Acronym / sponsor ID
- APPLY / VNSC-022020
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vascular Neurology of Southern California Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 9 Apr 2023 (estimated)
- Study completion
- 9 Apr 2023 (estimated)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm, single-center, post-market, real-world, investigator-initiated study.
| Arm | Type | Receives |
|---|---|---|
| Treatment with Optima Balt Coils | Experimental | Device: Optima Coil SystemThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patient participation in another study that may disrupt the results of this study
- Anticipated life expectancy of less than 12-months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optima Coil SystemAlso: Embolization of Intracranial Aneurysm, Optima Balt Coil System, Neurovascular Embolization DevicePatients who have qualified for endovascular coiling in effort to treat intracranial aneurysms were treated with | Device | Treatment with Optima Balt Coils |
Primary outcome
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.
8 secondary outcomes
Occlusion Scale Score
Time frame: Immediately post-procedure, 3-Months, and 12-Months
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.
Packing Density
Time frame: Result is known immediately post-procedure.
Fluro Time
Time frame: Result is known immediately post-procedure.
Other Devices Used
Time frame: Result is known immediately post-procedure.
Complications
Time frame: At all time points from procedure to 12 Months.
SAE
Time frame: At all time points from procedure to 12 Months.
Thromboembolic Events
Time frame: At all time points from procedure to 12 Months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Background: PubMed 16139655Molyneux 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.
- Background: PubMed 19193745Yoo 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.
- Background: PubMed 17327787Frazer 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.
- Background: PubMed 26251248Jalbert 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.
- Background: PubMed 20566113Guglielmi 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.
- Background: PubMed 17032854Katsaridis 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.
- Background: PubMed 12006273Tamatani 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.
- Background: PubMed 26047409Ayling 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.
- Background: PubMed 24898735Mascitelli 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.
- Background: PubMed 5635959Hunt 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.
- Background: PubMed 3363593van 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.
- Results publication: PubMed 9933290Brilstra 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad A Taqi, MD principal investigator
Vascular Neurology of Southern California
Anastasia Vechera, BA study director
Vascular Neurology of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optima Coil System in people with Aneurysm and Intracranial Aneurysm, run by Vascular Neurology of Southern California Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anastasia Vechera, BA (805-242-4884 ext. 2, avechera@vnsc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occlusion Rates (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04499508, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.