An interventional study of Hybrid Operating Techniques in Intracranial Aneurysm, sponsored by liuxingju. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by liuxingju · Not applicable, Interventional, and Treatment
To evaluate the clinical benefits and risks of hybrid operating techniques in management of complex intracranial aneurysms, which could coexists with multiple risk factors.
Purpose: Have an evaluation of clinical benefits and risks of hybrid operating techniques in management of complex intracranial aneurysms (CIAs), which could coexists with multiple risk factors. Meanwhile, as a new cooperative interventional modality, optimized workflows, technical key knots and operation routines will be explored in the study.
Objects: Patients with CIAs, coincident with inclusion and exclusion criterion and admitted in participating organizations.
Methods: Patients will be distributed into 2 groups, including traditional therapy group(control group) and hybrid operating group(trial group), and conduct with traditional neurosurgical management or one-stage hybrid operating management correspondingly. Peri-operative mortality rate is considered to be the primary observing indicator, and morbidity rate of peri-operative cerebral hemorrhagic/ischemic event, morbidity rate of aneurysmal residuals, morbidity rate of neural functional deteriorations, and health-economic indicators are secondary indicators.The information of operations will be recorded in detail as evidence of optimization of workflow and technical key knots.
429 studies on the registry are indexed under Intracranial Aneurysm; 114 are open to participants now.
This study's planned enrollment of 258 is above the median of 115 across 208 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →liuxingju is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intervene with hybrid operating techniques, eg. microsurgical clipping+endovascular coiling or with the assistant of balloon occlusion.
Procedure: Hybrid Operating Techniques
The aneurysms will be executed by traditional procedure, including microsurgical clipping, endovascular coiling or stenting, etc.
Procedure: Hybrid Operating Techniques
It is a cooperation of existing endovascular interventional techniques and microsurgical techniques. Different from traditional management, hybrid operating techniques make it possible for 2 existing techniques conducting simultaneously in a hybrid operating theater. It optimizes the traditional microsurgical techniques for complex intracranial aneurysms and avoids the transportation of patients and the risks of intervals between stages in traditional ones. It includes balloon-assisted parental arterial occlusion, one-stage aneurysm clipping/wrapping/isolation and embolization/diverter implantation, etc.
Also known as: microsurgical clipping, microsurgical dissection, microsurgical wrapping, microsurgical isolation, endovascular coiling, balloon-assisted occlusion, flow diverter
operation-related mortality rate
the mortality rate related to the operation
Time frame: From the time of operation begin to 48 hours after operation
Morbidity rate of peri-operative intracranial hemorrhage
Intracranial hemorrhagic events happening during the peri-operative period, including subarachnoid hemorrhage, intracranial hemorrhage, intraventricular hemorrhage caused by the rupture of aneurysms with neuro-imaging evidence.
Time frame: From date of admission to the 7 days after operation
Morbidity rate of peri-operative intracranial ischemic events
The intracranial ischemic events happening during the peri-operative period, including operation-related infarction, embolization, etc. With neuro-imaging evidence.
Time frame: From date of admission to 7 days after operation
Residual rate of aneurysms
the morbidity rate of aneurysmal residue, with post-operative DSA/CTA evidence
Time frame: the date of first post-operative cerebrovascular angiography is conducted, up to 3 months after operation
Morbidity rate of neural functional deterioration in 48 hours after operation
The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores
Time frame: 48 hours after operation, ±6 hours
Morbidity rate of neural functional deterioration in 7 days
The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores
Time frame: 7 days after operation, ±2 days
Morbidity rate of neural functional deterioration in 3 months
The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores
Time frame: the 3rd month after operation, ±1 week
Morbidity rate of neural functional deterioration in 6 months
The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores
Time frame: the 6th month after operation, ±1 week
Morbidity rate of neural functional deterioration in 12 months
The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores
Time frame: the 12th month after operation, ±1 week
Treatment-related costs
All expenses cost in hospital relating to the aiming disease
Time frame: through study completion, an average of 1 year
Duration of hospitalization
Total hospitalization of all stages of treatments to IAs, including admissions for evaluation, operation, and DSA
Time frame: through study completion, an average of 1 year
Duration of total operating time
Total operating time of all procedures, including operation, and DSA
Time frame: through study completion, an average of 1 year
Plan to share: Undecided — the IPD will be open to public researchers in 6 months after the study closed.
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
liuxingju