Intracranial AneurysmGALA-FDNCT06416657
General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter
A study testing Different anesthesia methods, namely local anesthesia and general anesthesia in people with Intracranial Aneurysm, run by Ming Lv at 1 site in China.
Trial summary
The prevalence of unruptured intracranial aneurysm (UIA) in the population is about 2%-7%, and once it ruptures and bleeds, the rate of disability and death is extremely high, with 10%-15% of patients dying suddenly before they can seek medical attention, 35% of first-time bleeders, and 60%-80% of second-time… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Different anesthesia methods, namely local anesthesia and general anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old and ≤80 years old, gender is not limited;
- Patients with previously untreated unruptured intracranial aneurysm (UIA) clearly diagnosed by DSA, CTA, or MRA;
- UIA maximum diameter <15mm;
- Baseline mRS score ≤2;
- UIAs planned for treated with PED;
- Patients voluntarily participated in this study and signed an informed consent form.
Who cannot join
- The aneurysms are located distal to the anterior cerebral artery (including the anterior communicating artery), distal to the M2 segment of the middle cerebral artery, and distal to the basilar artery;
- Those who are allergic to any components of the anesthetic drugs;
- Severe symptoms associated with the target aneurysm at the time of diagnosis, with mRS score ≥3;
- Pregnant and lactating female patients;
- Severe hepatic dysfunction (ALT or AST >three times the normal upper limit) or severe renal dysfunction (creatinine clearance rate <30 mL/min) before randomisation;
- Patients with metal implants in the body (e.g., cardiac stents, cardiac prosthetic valves, pacemakers, metal joints, steel plates, non-removable metal dentures, etc.);
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- Patients known to suffer from dementia or psychiatric diseases and claustrophobia can not complete the magnetic resonance examination;
- Patients with other serious diseases combined at the time of diagnosis with an expected survival time of less than 1 year;
- Patients who are participating in clinical trials of other drugs or devices;
- Other conditions that, in the judgment of the investigator, exist that are unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100010
Ming Lv, MD,PhD, 13701376177, dragontiger@163.com
About this study
Official title: General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter: an Exploratory Randomized Clinical Trial
The prevalence of unruptured intracranial aneurysm (UIA) in the population is about 2%-7%, and once it ruptures and bleeds, the rate of disability and death is extremely high, with 10%-15% of patients dying suddenly before they can seek medical attention, 35% of first-time bleeders, and 60%-80% of second-time bleeders. Survivors are often disabled. Therefore, there is a broad consensus that UIA with surgical indication should be aggressively intervened. The efficacy and safety of flow diverter (FD) in the treatment of UIA has been confirmed by many large clinical trials. Currently, FD placement for UIA is performed under general anesthesia (GA) in most centers, however, some studies have observed that FD placement under local anesthesia (LA) is not as effective as FD placement under general anesthesia and have demonstrated the feasibility of FD placement under local anesthesia (LA) with high technical success rates and low perioperative complication rates and mortality. However, the retrospective design and relatively limited sample size of the above studies may introduce significant bias and affect the confidence of the conclusions. Therefore, the present trial was designed as a randomized controlled trial with the aim of comparing the safety and efficacy of GA and LA in UIA patients undergoing FD placement. The results of this study will help inform future multicenter trials to validate the impact of anesthesia choice on the safety and efficacy in UIA patients undergoing FD placement.
- Conditions
- Intracranial Aneurysm
- Being tested
- Different anesthesia methods, namely local anesthesia and general anesthesia
- Keywords
- Unruptured intracranial aneurysm, Flow diverter, General anesthesia, Local anesthesia
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different anesthesia methods, namely local anesthesia and general anesthesiaOther
Patients in the local anesthesia group received only local anesthesia at the femoral artery puncture site without anesthesia drugs such as conscious sedation.
Patients in the general anesthesia group received not only local anesthesia at the femoral artery puncture site, but also fast-induction anesthesia with tracheal intubation or laryngeal mask insertion using isoproterenol, remifentanil, and muscle relaxants.
| Study group | Role | What they receive |
|---|---|---|
| Local anesthesia group | Experimental | Patients in the local anesthesia group received only local anesthesia at the femoral artery puncture site without anesthesia drugs such as conscious sedation. Receives: Other: Different anesthesia methods, namely local anesthesia and general anesthesia |
| General anesthesia group | Active comparator | Patients in the general anesthesia group received not only local anesthesia at the femoral artery puncture site, but also fast-induction anesthesia with tracheal intubation or laryngeal mask insertion using propofol, remifentanil, and rocuronium. Receives: Other: Different anesthesia methods, namely local anesthesia and general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Good neurologic status
Defined as an mRS score of ≤2 (i.e., asymptomatic or without significant disability)
Measured: 90 days after intervention
Secondary outcomes (12)
Newly developed cerebral ischemic foci
Determination was based on DWI sequences of cranial MRI
Measured: Within 48 hours of flow diverter placement
Status of cognitive function
Cognitive functioning status assessed by the Montreal Cognitive Assessment (MoCA). The MoCA was developed by Prof. Nasreddine in 2004 as a rapid screening tool for mild cognitive impairment.The MoCA has a total score of 30, with a minimum score of 0. Higher scores indicate better cognitive functioning. By scoring each domain, more detailed information can be obtained to determine the extent of deficits and abnormalities in cognitive functioning. In general, a score of 26 and above can be considered normal cognitive functioning, while a score below 26 may indicate the presence of cognitive impairment or dementia. 18-26 is considered mild cognitive impairment, 10-17 is considered moderate cognitive impairment, and <10 is considered severe cognitive impairment.
Measured: 90 days after intervention
Postoperative perioperative complication rate
The perioperative period is defined as up to 7 days after the intervention
Measured: 7 days after intervention
Overall complication rate at 90 days postoperatively
Overall complication rate at 90 days postoperatively
Measured: 90 days after intervention
Mortality at 90 days post-intervention
Mortality at 90 days post-intervention
Measured: 90 days after intervention
Proportion of local anesthesia converted to general anesthesia during interventional procedures
For patient safety, patients in LA will be referred to GA if they develop the following conditions a) The patient becomes comatose and unconscious; b) Glasgow coma scale (GCS) <8; c) EtCO2 ≥ 60 mmHg or SpO2 < 94% despite supplemental oxygen; d) Patient has vomiting, vertigo, agitation that is not controlled by antiemetics and sedation; e) Seizures; f) Complications of endovascular therapy, such as intracerebral hemorrhage from a ruptured aneurysm or SAH.
Measured: Immediately after intervention
Anesthesia induction time, time from femoral artery puncture to femoral artery suture, anesthesia recovery time, and total operative time
Record the above times in the immediate postoperative period
Measured: Immediately after surgery
Incidence of intraoperative vasospasm
Incidence of intraoperative vasospasm
Measured: Immediately after surgery
Pain scores at 24 hours postoperatively
Measured with a VAS ranging from 0 (no pain) to 10 (intolerable)
Measured: 24 hours after intervention
Pain medication use within 24 hours after surgery
Pain medication use within 24 hours after surgery
Measured: 24 hours after intervention
Length of hospitalization
Length of hospitalization
Measured: Until the patient was discharged from the hospital, an average of 1 week.
Hospitalization costs
Hospitalization costs
Measured: Until the patient was discharged from the hospital, an average of 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jun 2024
- Primary completion12 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Intracranial 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ming Lv
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Peking University International Hospital, Beijing Anzhen Hospital, The Affiliated Lianyungang Hospital of Xuzhou Medical University, First Affiliated Hospital, Sun Yat-Sen University, Third Medical Center of Chinese PLA General Hospital, The Second Artillery General Hospital
- Responsible party
- Sponsor-investigator, Ming Lv, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416657
- Sponsor's protocol ID
- dragontiger
- Acronym
- GALA-FD
- Status last verified
- Aug 2026
- First submitted
- 8 May 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kang H, Zhou Y, Luo B, Lv N, Zhang H, Li T, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Liu J. Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis. Neurotherapeutics. 2021 Apr;18(2):1198-1206. doi: 10.1007/s13311-020-00990-8. Epub 2021 Jan 14.
PubMed 33447904Rangel-Castilla L, Cress MC, Munich SA, Sonig A, Krishna C, Gu EY, Snyder KV, Hopkins LN, Siddiqui AH, Levy EI. Feasibility, Safety, and Periprocedural Complications of Pipeline Embolization for Intracranial Aneurysm Treatment Under Conscious Sedation: University at Buffalo Neurosurgery Experience. Neurosurgery. 2015 Sep;11 Suppl 3:426-30. doi: 10.1227/NEU.0000000000000864.
PubMed 26284351Griessenauer CJ, Shallwani H, Adeeb N, Gupta R, Rangel-Castilla L, Siddiqui AH, Levy EI, Boone MD, Thomas AJ, Ogilvy CS. Conscious Sedation Versus General Anesthesia for the Treatment of Cerebral Aneurysms with Flow Diversion: A Matched Cohort Study. World Neurosurg. 2017 Jun;102:1-5. doi: 10.1016/j.wneu.2017.02.111. Epub 2017 Mar 6.
PubMed 28279774Simonsen CZ, Sorensen LH, Juul N, Johnsen SP, Yoo AJ, Andersen G, Rasmussen M. Anesthetic strategy during endovascular therapy: General anesthesia or conscious sedation? (GOLIATH - General or Local Anesthesia in Intra Arterial Therapy) A single-center randomized trial. Int J Stroke. 2016 Dec;11(9):1045-1052. doi: 10.1177/1747493016660103. Epub 2016 Jul 12.
PubMed 27405859Kilic Y, Bas SS, Aykac O, Ozdemir AO. Nonoperating Room Anesthesia for Interventional Neuroangiographic Procedures: Outcomes of 105 Patients. J Stroke Cerebrovasc Dis. 2020 Feb;29(2):104495. doi: 10.1016/j.jstrokecerebrovasdis.2019.104495. Epub 2019 Dec 2.
PubMed 31806453Siddiqui AH, Kan P, Abla AA, Hopkins LN, Levy EI. Complications after treatment with pipeline embolization for giant distal intracranial aneurysms with or without coil embolization. Neurosurgery. 2012 Aug;71(2):E509-13; discussion E513. doi: 10.1227/NEU.0b013e318258e1f8.
PubMed 22710418Park MS, Albuquerque FC, Nanaszko M, Sanborn MR, Moon K, Abla AA, McDougall CG. Critical assessment of complications associated with use of the Pipeline Embolization Device. J Neurointerv Surg. 2015 Sep;7(9):652-9. doi: 10.1136/neurintsurg-2014-011265. Epub 2014 Jun 26.
PubMed 24968879Chalouhi N, Chitale R, Starke RM, Jabbour P, Tjoumakaris S, Dumont AS, Rosenwasser RH, Gonzalez LF. Treatment of recurrent intracranial aneurysms with the Pipeline Embolization Device. J Neurointerv Surg. 2014 Jan;6(1):19-23. doi: 10.1136/neurintsurg-2012-010612. Epub 2013 Jan 23.
PubMed 23345630Abou-Chebl A, Lin R, Hussain MS, Jovin TG, Levy EI, Liebeskind DS, Yoo AJ, Hsu DP, Rymer MM, Tayal AH, Zaidat OO, Natarajan SK, Nogueira RG, Nanda A, Tian M, Hao Q, Kalia JS, Nguyen TN, Chen M, Gupta R. Conscious sedation versus general anesthesia during endovascular therapy for acute anterior circulation stroke: preliminary results from a retrospective, multicenter study. Stroke. 2010 Jun;41(6):1175-9. doi: 10.1161/STROKEAHA.109.574129. Epub 2010 Apr 15.
PubMed 20395617McDonald JS, Brinjikji W, Rabinstein AA, Cloft HJ, Lanzino G, Kallmes DF. Conscious sedation versus general anaesthesia during mechanical thrombectomy for stroke: a propensity score analysis. J Neurointerv Surg. 2015 Nov;7(11):789-94. doi: 10.1136/neurintsurg-2014-011373. Epub 2014 Sep 26.
PubMed 25261440Rajbhandari S, Matsukawa H, Uchida K, Shirakawa M, Yoshimura S. Clinical Results of Flow Diverter Treatments for Cerebral Aneurysms under Local Anesthesia. Brain Sci. 2022 Aug 13;12(8):1076. doi: 10.3390/brainsci12081076.
PubMed 36009139Hanel RA, Kallmes DF, Lopes DK, Nelson PK, Siddiqui A, Jabbour P, Pereira VM, Szikora Istvan I, Zaidat OO, Bettegowda C, Colby GP, Mokin M, Schirmer C, Hellinger FR, Given Ii C, Krings T, Taussky P, Toth G, Fraser JF, Chen M, Priest R, Kan P, Fiorella D, Frei D, Aagaard-Kienitz B, Diaz O, Malek AM, Cawley CM, Puri AS. Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results. J Neurointerv Surg. 2020 Jan;12(1):62-66. doi: 10.1136/neurintsurg-2019-015091. Epub 2019 Jul 15.
PubMed 31308197Luo B, Kang H, Zhang H, Li T, Liu J, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X. Pipeline Embolization device for intracranial aneurysms in a large Chinese cohort: factors related to aneurysm occlusion. Ther Adv Neurol Disord. 2020 Nov 2;13:1756286420967828. doi: 10.1177/1756286420967828. eCollection 2020.
PubMed 33224273Pierot L, Spelle L, Berge J, Januel AC, Herbreteau D, Aggour M, Piotin M, Biondi A, Barreau X, Mounayer C, Papagiannaki C, Lejeune JP, Gauvrit JY, Derelle AL, Chabert E, Costalat V. SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results. J Neurointerv Surg. 2019 Feb;11(2):184-189. doi: 10.1136/neurintsurg-2018-014261. Epub 2018 Oct 8.
PubMed 30297539Becske T, Brinjikji W, Potts MB, Kallmes DF, Shapiro M, Moran CJ, Levy EI, McDougall CG, Szikora I, Lanzino G, Woo HH, Lopes DK, Siddiqui AH, Albuquerque FC, Fiorella DJ, Saatci I, Cekirge SH, Berez AL, Cher DJ, Berentei Z, Marosfoi M, Nelson PK. Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms: Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial. Neurosurgery. 2017 Jan 1;80(1):40-48. doi: 10.1093/neuros/nyw014.
PubMed 28362885
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter: an Exploratory Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06416657
- Acronym / sponsor ID
- GALA-FD / dragontiger
- Conditions
- Intracranial Aneurysm
- Keywords
- Unruptured intracranial aneurysm, Flow diverter, General anesthesia, Local anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Ming LvUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Peking University International Hospital, Beijing Anzhen Hospital, The Affiliated Lianyungang Hospital of Xuzhou Medical University, First Affiliated Hospital, Sun Yat-Sen University, Third Medical Center of Chinese PLA General Hospital, The Second Artillery General Hospital
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 12 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 May 2024 (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.
The prevalence of unruptured intracranial aneurysm (UIA) in the population is about 2%-7%, and once it ruptures and bleeds, the rate of disability and death is extremely high, with 10%-15% of patients dying suddenly before they can seek medical attention, 35% of first-time bleeders, and 60%-80% of second-time bleeders. Survivors are often disabled. Therefore, there is a broad consensus that UIA with surgical indication should be aggressively intervened. The efficacy and safety of flow diverter (FD) in the treatment of UIA has been confirmed by many large clinical trials. Currently, FD placement for UIA is performed under general anesthesia (GA) in most centers, however, some studies have observed that FD placement under local anesthesia (LA) is not as effective as FD placement under general anesthesia and have demonstrated the feasibility of FD placement under local anesthesia (LA) with high technical success rates and low perioperative complication rates and mortality. However, the retrospective design and relatively limited sample size of the above studies may introduce significant bias and affect the confidence of the conclusions. Therefore, the present trial was designed as a randomized controlled trial with the aim of comparing the safety and efficacy of GA and LA in UIA patients undergoing FD placement. The results of this study will help inform future multicenter trials to validate the impact of anesthesia choice on the safety and efficacy in UIA patients undergoing FD placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local anesthesia group | Experimental | Other: Different anesthesia methods, namely local anesthesia and general anesthesiaPatients in the local anesthesia group received only local anesthesia at the femoral artery puncture site without anesthesia drugs such as conscious sedation. |
| General anesthesia group | Active comparator | Other: Different anesthesia methods, namely local anesthesia and general anesthesiaPatients in the general anesthesia group received not only local anesthesia at the femoral artery puncture site, but also fast-induction anesthesia with tracheal intubation or laryngeal mask insertion using propofol, remifentanil, and rocuronium. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years old and ≤80 years old, gender is not limited;
- Patients with previously untreated unruptured intracranial aneurysm (UIA) clearly diagnosed by DSA, CTA, or MRA;
- UIA maximum diameter <15mm;
- Baseline mRS score ≤2;
- UIAs planned for treated with PED;
Key exclusion criteria (10 listed)
- The aneurysms are located distal to the anterior cerebral artery (including the anterior communicating artery), distal to the M2 segment of the middle cerebral artery, and distal to the basilar artery;
- Those who are allergic to any components of the anesthetic drugs;
- Severe symptoms associated with the target aneurysm at the time of diagnosis, with mRS score ≥3;
- Pregnant and lactating female patients;
- Severe hepatic dysfunction (ALT or AST >three times the normal upper limit) or severe renal dysfunction (creatinine clearance rate <30 mL/min) before randomisation;
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 |
|---|---|---|
| Different anesthesia methods, namely local anesthesia and general anesthesiaPatients in the local anesthesia group received only local anesthesia at the femoral artery puncture site without anesthesia drugs such as conscious sedation. Patients in the general anesthesia group received not only local anesthesia at the femoral artery puncture site, but also fast-induction anesthesia with tracheal intubation or laryngeal mask insertion using isoproterenol, remifentanil, and muscle relaxants. | Other | General anesthesia group, Local anesthesia group |
Primary outcome
Good neurologic status
Time frame: 90 days after intervention
Defined as an mRS score of ≤2 (i.e., asymptomatic or without significant disability)
12 secondary outcomes
Newly developed cerebral ischemic foci
Time frame: Within 48 hours of flow diverter placement
Status of cognitive function
Time frame: 90 days after intervention
Postoperative perioperative complication rate
Time frame: 7 days after intervention
Overall complication rate at 90 days postoperatively
Time frame: 90 days after intervention
Mortality at 90 days post-intervention
Time frame: 90 days after intervention
Proportion of local anesthesia converted to general anesthesia during interventional procedures
Time frame: Immediately after intervention
Anesthesia induction time, time from femoral artery puncture to femoral artery suture, anesthesia recovery time, and total operative time
Time frame: Immediately after surgery
Incidence of intraoperative vasospasm
Time frame: Immediately after surgery
Pain scores at 24 hours postoperatively
Time frame: 24 hours after intervention
Pain medication use within 24 hours after surgery
Time frame: 24 hours after intervention
Length of hospitalization
Time frame: Until the patient was discharged from the hospital, an average of 1 week.
Hospitalization costs
Time frame: Until the patient was discharged from the hospital, an average of 1 week.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Results publication: PubMed 33447904Kang H, Zhou Y, Luo B, Lv N, Zhang H, Li T, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Liu J. Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis. Neurotherapeutics. 2021 Apr;18(2):1198-1206. doi: 10.1007/s13311-020-00990-8. Epub 2021 Jan 14.
- Results publication: PubMed 26284351Rangel-Castilla L, Cress MC, Munich SA, Sonig A, Krishna C, Gu EY, Snyder KV, Hopkins LN, Siddiqui AH, Levy EI. Feasibility, Safety, and Periprocedural Complications of Pipeline Embolization for Intracranial Aneurysm Treatment Under Conscious Sedation: University at Buffalo Neurosurgery Experience. Neurosurgery. 2015 Sep;11 Suppl 3:426-30. doi: 10.1227/NEU.0000000000000864.
- Results publication: PubMed 28279774Griessenauer CJ, Shallwani H, Adeeb N, Gupta R, Rangel-Castilla L, Siddiqui AH, Levy EI, Boone MD, Thomas AJ, Ogilvy CS. Conscious Sedation Versus General Anesthesia for the Treatment of Cerebral Aneurysms with Flow Diversion: A Matched Cohort Study. World Neurosurg. 2017 Jun;102:1-5. doi: 10.1016/j.wneu.2017.02.111. Epub 2017 Mar 6.
- Results publication: PubMed 27405859Simonsen CZ, Sorensen LH, Juul N, Johnsen SP, Yoo AJ, Andersen G, Rasmussen M. Anesthetic strategy during endovascular therapy: General anesthesia or conscious sedation? (GOLIATH - General or Local Anesthesia in Intra Arterial Therapy) A single-center randomized trial. Int J Stroke. 2016 Dec;11(9):1045-1052. doi: 10.1177/1747493016660103. Epub 2016 Jul 12.
- Results publication: PubMed 31806453Kilic Y, Bas SS, Aykac O, Ozdemir AO. Nonoperating Room Anesthesia for Interventional Neuroangiographic Procedures: Outcomes of 105 Patients. J Stroke Cerebrovasc Dis. 2020 Feb;29(2):104495. doi: 10.1016/j.jstrokecerebrovasdis.2019.104495. Epub 2019 Dec 2.
- Results publication: PubMed 22710418Siddiqui AH, Kan P, Abla AA, Hopkins LN, Levy EI. Complications after treatment with pipeline embolization for giant distal intracranial aneurysms with or without coil embolization. Neurosurgery. 2012 Aug;71(2):E509-13; discussion E513. doi: 10.1227/NEU.0b013e318258e1f8.
- Results publication: PubMed 24968879Park MS, Albuquerque FC, Nanaszko M, Sanborn MR, Moon K, Abla AA, McDougall CG. Critical assessment of complications associated with use of the Pipeline Embolization Device. J Neurointerv Surg. 2015 Sep;7(9):652-9. doi: 10.1136/neurintsurg-2014-011265. Epub 2014 Jun 26.
- Results publication: PubMed 23345630Chalouhi N, Chitale R, Starke RM, Jabbour P, Tjoumakaris S, Dumont AS, Rosenwasser RH, Gonzalez LF. Treatment of recurrent intracranial aneurysms with the Pipeline Embolization Device. J Neurointerv Surg. 2014 Jan;6(1):19-23. doi: 10.1136/neurintsurg-2012-010612. Epub 2013 Jan 23.
- Results publication: PubMed 20395617Abou-Chebl A, Lin R, Hussain MS, Jovin TG, Levy EI, Liebeskind DS, Yoo AJ, Hsu DP, Rymer MM, Tayal AH, Zaidat OO, Natarajan SK, Nogueira RG, Nanda A, Tian M, Hao Q, Kalia JS, Nguyen TN, Chen M, Gupta R. Conscious sedation versus general anesthesia during endovascular therapy for acute anterior circulation stroke: preliminary results from a retrospective, multicenter study. Stroke. 2010 Jun;41(6):1175-9. doi: 10.1161/STROKEAHA.109.574129. Epub 2010 Apr 15.
- Results publication: PubMed 25261440McDonald JS, Brinjikji W, Rabinstein AA, Cloft HJ, Lanzino G, Kallmes DF. Conscious sedation versus general anaesthesia during mechanical thrombectomy for stroke: a propensity score analysis. J Neurointerv Surg. 2015 Nov;7(11):789-94. doi: 10.1136/neurintsurg-2014-011373. Epub 2014 Sep 26.
- Results publication: PubMed 36009139Rajbhandari S, Matsukawa H, Uchida K, Shirakawa M, Yoshimura S. Clinical Results of Flow Diverter Treatments for Cerebral Aneurysms under Local Anesthesia. Brain Sci. 2022 Aug 13;12(8):1076. doi: 10.3390/brainsci12081076.
- Results publication: PubMed 31308197Hanel RA, Kallmes DF, Lopes DK, Nelson PK, Siddiqui A, Jabbour P, Pereira VM, Szikora Istvan I, Zaidat OO, Bettegowda C, Colby GP, Mokin M, Schirmer C, Hellinger FR, Given Ii C, Krings T, Taussky P, Toth G, Fraser JF, Chen M, Priest R, Kan P, Fiorella D, Frei D, Aagaard-Kienitz B, Diaz O, Malek AM, Cawley CM, Puri AS. Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results. J Neurointerv Surg. 2020 Jan;12(1):62-66. doi: 10.1136/neurintsurg-2019-015091. Epub 2019 Jul 15.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different anesthesia methods, namely local anesthesia and general anesthesia in people with Intracranial Aneurysm, run by Ming Lv at 1 site in China.
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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 25 Aug 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linggen Dong, MD (18844738529, donglinggen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good neurologic status (time frame: 90 days after intervention). 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 NCT06416657, which also lists 21 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 25 Aug 2026.