Intracranial AneurysmCIA-HOTsNCT03206853
Surgical Management of Complex Intracranial Aneurysms With Hybrid Operating Techniques
A study testing Hybrid Operating Techniques in people with Intracranial Aneurysm, run by liuxingju at 1 site in China.
Trial summary
To evaluate the clinical benefits and risks of hybrid operating techniques in management of complex intracranial aneurysms, which could coexists with multiple risk factors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Hybrid Operating Techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Dec 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- with diagnosed complex intracranial aneurysm by digital subtraction angiography(DSA);
- got SAH in history;
- neural functional deficits due to aneurysms;
- with <4 in Hunt-Hess Grades;
- ≥5.0mm in the maximum diameter;
- <70 years old;
- with irregular morphological features and high rupture risk.
Who cannot join
- >70 in age, with low rupture risk;
- cannot tolerant the operation;
- patient or relative refuses to participate the trail;
- SAH patient with ≥4 Hunt-Hess grading system;
- <5.0mm in the maximum diameter.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, 0086
liu xingju, MD, 008615011476305, liuxingju006@163.com
About this study
Official title: Clinical Trail of Hybrid Operating Technique in Management of Complex Intracranial Aneurysms With Coexistence of Multiple Risk Factors
To evaluate the clinical benefits and risks of hybrid operating techniques in management of complex intracranial aneurysms, which could coexists with multiple risk factors.
Read the detailed description
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.
- Conditions
- Intracranial Aneurysm
- Being tested
- Hybrid Operating Techniques
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Operating TechniquesProcedure or surgery
Also called microsurgical clipping, microsurgical dissection, microsurgical wrapping, microsurgical isolation
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.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid operation group | Experimental | Intervene with hybrid operating techniques, eg. microsurgical clipping+endovascular coiling or with the assistant of balloon occlusion. Receives: Procedure: Hybrid Operating Techniques |
| Traditional therapy group | Other | The aneurysms will be executed by traditional procedure, including microsurgical clipping, endovascular coiling or stenting, etc. Receives: Procedure: Hybrid Operating Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
operation-related mortality rate
the mortality rate related to the operation
Measured: From the time of operation begin to 48 hours after operation
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: the 12th month after operation, ±1 week
Treatment-related costs
All expenses cost in hospital relating to the aiming disease
Measured: 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
Measured: through study completion, an average of 1 year
Duration of total operating time
Total operating time of all procedures, including operation, and DSA
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study startApr 2016
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Traditional therapy group：the aneurysms will be executed by traditional procedure, including microsurgical clipping, endovascular coiling or stenting, etc. Hybrid operation group: Intervene with hybrid operating techniques, eg. microsurgical clipping+endovascular coiling or with the assistant of balloon occlusion.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- liuxingju
- Sponsor type
- Other government
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Sponsor-investigator, liuxingju, Ministry of Science and Technology of the People´s Republic of China
- Investigators
- Jizong Zhao, MD, Study director, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206853
- Sponsor's protocol ID
- BJTTH-004
- Acronym
- CIA-HOTs
- Status last verified
- Jun 2017
- First submitted
- 26 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the IPD will be open to public researchers in 6 months after the study closed.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trail of Hybrid Operating Technique in Management of Complex Intracranial Aneurysms With Coexistence of Multiple Risk Factors
- ClinicalTrials.gov ID
- NCT03206853
- Acronym / sponsor ID
- CIA-HOTs / BJTTH-004
- Conditions
- Intracranial Aneurysm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- liuxingjuOther government
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 Jul 2017 (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.
To evaluate the clinical benefits and risks of hybrid operating techniques in management of complex intracranial aneurysms, which could coexists with multiple risk factors.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Traditional therapy group：the aneurysms will be executed by traditional procedure, including microsurgical clipping, endovascular coiling or stenting, etc. Hybrid operation group: Intervene with hybrid operating techniques, eg. microsurgical clipping+endovascular coiling or with the assistant of balloon occlusion.
| Arm | Type | Receives |
|---|---|---|
| Hybrid operation group | Experimental | Procedure: Hybrid Operating TechniquesIntervene with hybrid operating techniques, eg. microsurgical clipping+endovascular coiling or with the assistant of balloon occlusion. |
| Traditional therapy group | Other | Procedure: Hybrid Operating TechniquesThe aneurysms will be executed by traditional procedure, including microsurgical clipping, endovascular coiling or stenting, etc. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- with diagnosed complex intracranial aneurysm by digital subtraction angiography(DSA);
- got SAH in history;
- neural functional deficits due to aneurysms;
- with <4 in Hunt-Hess Grades;
- ≥5.0mm in the maximum diameter;
Key exclusion criteria (5 listed)
- >70 in age, with low rupture risk;
- cannot tolerant the operation;
- patient or relative refuses to participate the trail;
- SAH patient with ≥4 Hunt-Hess grading system;
- <5.0mm in the maximum diameter.
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 |
|---|---|---|
| Hybrid Operating TechniquesAlso: microsurgical clipping, microsurgical dissection, microsurgical wrapping, microsurgical isolationIt 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. | Procedure or surgery | Hybrid operation group, Traditional therapy group |
Primary outcome
operation-related mortality rate
Time frame: From the time of operation begin to 48 hours after operation
the mortality rate related to the operation
11 secondary outcomes
Morbidity rate of peri-operative intracranial hemorrhage
Time frame: From date of admission to the 7 days after operation
Morbidity rate of peri-operative intracranial ischemic events
Time frame: From date of admission to 7 days after operation
Residual rate of aneurysms
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
Time frame: 48 hours after operation, ±6 hours
Morbidity rate of neural functional deterioration in 7 days
Time frame: 7 days after operation, ±2 days
Morbidity rate of neural functional deterioration in 3 months
Time frame: the 3rd month after operation, ±1 week
Morbidity rate of neural functional deterioration in 6 months
Time frame: the 6th month after operation, ±1 week
Morbidity rate of neural functional deterioration in 12 months
Time frame: the 12th month after operation, ±1 week
Treatment-related costs
Time frame: through study completion, an average of 1 year
Duration of hospitalization
Time frame: through study completion, an average of 1 year
Duration of total operating time
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Individual participant dataSharing planned: Undecided. the IPD will be open to public researchers in 6 months after the study closed.
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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.
Jizong Zhao, MD study director
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Operating Techniques in people with Intracranial Aneurysm, run by liuxingju 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 7 inclusion and 5 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 2 Jul 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xingju Liu, MD (86-15011476305, liuxingju006@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operation-related mortality rate (time frame: From the time of operation begin to 48 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2017.