Intracranial AneurysmHOT-CIACSNCT03204435
Hybrid Operating Treatment of Coexistence of Intracranial Aneurysms and Cerebrovascular Stenosis
A study testing Microsurgical aneurysmal operating techniques, endovascular techniques for cerebrovascular stenosis and endovascular techniques for intracranial aneurysms in people with Intracranial Aneurysm and Cerebrovascular Stenosis, run by liuxingju at 1 site in China.
Trial summary
To evaluate the clinical benefits and risks of hybrid operating techniques in management of intracranial aneurysms with coexistence of atherosclerotic intracranial arterial stenosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intracranial Aneurysm, Cerebrovascular Stenosis, Atheroscleroses, Cerebral
- What is being tested?
- Microsurgical aneurysmal operating techniques, endovascular techniques for cerebrovascular stenosis and endovascular techniques for intracranial aneurysms
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- Jun 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
- For aneurysms:
- 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;
Show all 18Show fewer
- <70 years old;
- with irregular morphological features and high rupture risk.
- and for stenosis
- Intracranial vessels:
- >50% in rate of stenosis with ischemic symptoms/perfusing evidence/lacunar infarction in supplying territory, failed in conservative treatment;
- with a deliverable position of intracranial stents devices.
- or Vertebral arterial system:
- ≥70% in the rate of stenosis, with contralateral vertebral arterial occlusion;
- symptomatic vertebral arterial stenosis, accompanied with posterior inferior cerebellum artery derived from the affected artery and related symptoms are caused/clinical benefits can be achieved through angioplasty.
- or Extracranial arterial system:
- ≥70% in the rate of stenosis with symptoms;
- nonsymptomatic patients, ≥70% in the rate of stenosis , with perfusing evidence.
Who cannot join
- >70 in age, with low rupture risk;
- stroke history in 6 weeks (contraindication for endovascular intervention);
- coexistence with intracranial tumor or AVM;
- cannot tolerant the operation;
- patient or relative refuses to participate the trail
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, 100050
Xingju Liu, MD, 86-010-670965423, liuxingju003@163.com
Mingze Wang, MD, 86-010-67096510, wmz_01@sina.com
About this study
Official title: Clinical Trail of Hybrid Operating Technique in Management of Intracranial Aneurysms With Coexistence of Atherosclerotic Intracranial Arterial Stenosis
To evaluate the clinical benefits and risks of hybrid operating techniques in management of intracranial aneurysms with coexistence of atherosclerotic intracranial arterial stenosis.
Read the detailed description
Purpose: Have an evaluation of clinical benefits and risks of hybrid operating techniques in management of intracranial aneurysms (IAs) with coexistence of atherosclerotic intracranial arterial stenosis (AIAS), whose management strategies are inconsistent. Meanwhile, as a new cooperative interventional modality, optimized workflows, technical key knots and operation routines will be explored in the study.
Objects: Patients with IAs with coexistence of AIAS, 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 multi-stage neurosurgical management or one-stage hybrid operating management correspondingly. The morbidity rate of peri-operative cerebral hemorrhagic/ischemic event is considered to be the primary observing indicator, and morbidity rate of peri-operative cerebral hemorrhagic/ischemic event, while peri-operative mortality rate, 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.
- Being tested
- Microsurgical aneurysmal operating techniques, endovascular techniques for cerebrovascular stenosis, endovascular techniques for intracranial aneurysms, carotid endarterectomy
- Medical subject headings
- Intracranial Aneurysm, Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microsurgical aneurysmal operating techniquesProcedure or surgery
Also called microsurgical aneurysmal clipping, microsurgical aneurysmal wrapping, microsurgical aneurysmal isolation
The microsurgical techniques used to evacuate the aneurysm out of circulation or reduce its risk of rupture by aneurysmal clipping, wrapping,or isolation.
endovascular techniques for cerebrovascular stenosisProcedure or surgery
Also called endovascular stenting, endovascular balloon dilatation
The endovascular techniques that recanalize the narrowed or occluded cerebrovascular, including stent implantation, balloon dilatation.
endovascular techniques for intracranial aneurysmsProcedure or surgery
Also called endovascular coiling, endovascular balloon occlusion, flow diverter
The endovascular techniques that embolize the cavity of aneurysms to reduce the risk of rupture, including coiling embolization, balloon-assisted occlusion.
carotid endarterectomyProcedure or surgery
A microsurgical technique to recanalize the stenosis or occluded proximal segment of carotid artery.
| Study group | Role | What they receive |
|---|---|---|
| Traditional therapy | Other | Consists of microsurgical aneurysmal operating techniques, endovascular techniques for intracranial aneurysms, endovascular techniques for cerebrovascular stenosis, and carotid endarterectomy, which are presented by stages. Receives: Procedure: Microsurgical aneurysmal operating techniques; Procedure: endovascular techniques for cerebrovascular stenosis; Procedure: endovascular techniques for intracranial aneurysms; Procedure: carotid endarterectomy |
| Hybrid operation | Experimental | Consists of microsurgical aneurysmal operating techniques, endovascular techniques for intracranial aneurysms, endovascular techniques for cerebrovascular stenosis, and carotid endarterectomy, which are presented in one-stage in hybrid operating theater. Receives: Procedure: Microsurgical aneurysmal operating techniques; Procedure: endovascular techniques for cerebrovascular stenosis; Procedure: endovascular techniques for intracranial aneurysms; Procedure: carotid endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
morbidity rate of peri-operative cerebral hemorrhagic events
the morbidity rate of cerebral hemorrhagic events, with significant neuro-image evidence, during the period of treatment, including SAH/ICH/IVH caused by IAs, and intracranial hemorrhages caused by interventions focusing on AIAS
Measured: through study completion, an average of 1 year
morbidity rate of peri-operative cerebral ischemic events
the morbidity rate of cerebral ischemic events, with significant neuro-image evidence, during the period of treatment, including all cerebral infarctions caused by interventions focusing on IAs and AIAS.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Peri-operative mortality rate
The mortality rate during the period of treatment
Measured: through study completion, an average of 1 year
Treatment-related costs
The total in-patient expenses of the aiming diseases, covering all treating stages
Measured: through study completion, an average of 1 year
Duration of hospitalization
The total hospitalizations for the treatment of aiming diseases, covering all treating stages
Measured: through study completion, an average of 1 year
Duration of total operating time
The total operating time, the sum of durations of multi-stages operation if several procedures are presented
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 startJun 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
- Patients of intracranial aneurysms with coexistence of cerebrovascular stenosis, coincident with inclusion and exclusion criterion, will be distributed into traditional therapy group(control group) and hybrid operating group(test group), and conduct with traditional neurosurgical management or one-stage hybrid operating management separately. Traditional therapy group: intervene the aneurysms and vascular stenosis unsimultaneously. Clipping procedure is preferred to aneurysms, while endovascular intervention is preferred to stenosis. Hybrid operation group: one-stage hybrid operating technique is conducted. The aneurysms and vascular stenosis will be executed via the cooperation of microsurgical procedure and endovascular interventional techniques.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 196 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
- NCT03204435
- Sponsor's protocol ID
- BJTTH-005
- Acronym
- HOT-CIACS
- Status last verified
- Jun 2017
- First submitted
- 27 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 Intracranial Aneurysms With Coexistence of Atherosclerotic Intracranial Arterial Stenosis
- ClinicalTrials.gov ID
- NCT03204435
- Acronym / sponsor ID
- HOT-CIACS / BJTTH-005
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- liuxingjuOther government
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- Jun 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 intracranial aneurysms with coexistence of atherosclerotic intracranial arterial stenosis.
Detailed description
Purpose: Have an evaluation of clinical benefits and risks of hybrid operating techniques in management of intracranial aneurysms (IAs) with coexistence of atherosclerotic intracranial arterial stenosis (AIAS), whose management strategies are inconsistent. Meanwhile, as a new cooperative interventional modality, optimized workflows, technical key knots and operation routines will be explored in the study.
Objects: Patients with IAs with coexistence of AIAS, 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 multi-stage neurosurgical management or one-stage hybrid operating management correspondingly. The morbidity rate of peri-operative cerebral hemorrhagic/ischemic event is considered to be the primary observing indicator, and morbidity rate of peri-operative cerebral hemorrhagic/ischemic event, while peri-operative mortality rate, 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
- Patients of intracranial aneurysms with coexistence of cerebrovascular stenosis, coincident with inclusion and exclusion criterion, will be distributed into traditional therapy group(control group) and hybrid operating group(test group), and conduct with traditional neurosurgical management or one-stage hybrid operating management separately. Traditional therapy group: intervene the aneurysms and vascular stenosis unsimultaneously. Clipping procedure is preferred to aneurysms, while endovascular intervention is preferred to stenosis. Hybrid operation group: one-stage hybrid operating technique is conducted. The aneurysms and vascular stenosis will be executed via the cooperation of microsurgical procedure and endovascular interventional techniques.
| Arm | Type | Receives |
|---|---|---|
| Traditional therapy | Other | Procedure: Microsurgical aneurysmal operating techniques, Procedure: endovascular techniques for cerebrovascular stenosis, Procedure: endovascular techniques for intracranial aneurysms, Procedure: carotid endarterectomyConsists of microsurgical aneurysmal operating techniques, endovascular techniques for intracranial aneurysms, endovascular techniques for cerebrovascular stenosis, and carotid endarterectomy, which are presented by stages. |
| Hybrid operation | Experimental | Procedure: Microsurgical aneurysmal operating techniques, Procedure: endovascular techniques for cerebrovascular stenosis, Procedure: endovascular techniques for intracranial aneurysms, Procedure: carotid endarterectomyConsists of microsurgical aneurysmal operating techniques, endovascular techniques for intracranial aneurysms, endovascular techniques for cerebrovascular stenosis, and carotid endarterectomy, which are presented in one-stage in hybrid operating theater. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- For aneurysms:
- 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;
Key exclusion criteria (5 listed)
- >70 in age, with low rupture risk;
- stroke history in 6 weeks (contraindication for endovascular intervention);
- coexistence with intracranial tumor or AVM;
- cannot tolerant the operation;
- patient or relative refuses to participate the trail
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 |
|---|---|---|
| Microsurgical aneurysmal operating techniquesAlso: microsurgical aneurysmal clipping, microsurgical aneurysmal wrapping, microsurgical aneurysmal isolationThe microsurgical techniques used to evacuate the aneurysm out of circulation or reduce its risk of rupture by aneurysmal clipping, wrapping,or isolation. | Procedure or surgery | Hybrid operation, Traditional therapy |
| endovascular techniques for cerebrovascular stenosisAlso: endovascular stenting, endovascular balloon dilatationThe endovascular techniques that recanalize the narrowed or occluded cerebrovascular, including stent implantation, balloon dilatation. | Procedure or surgery | Hybrid operation, Traditional therapy |
| endovascular techniques for intracranial aneurysmsAlso: endovascular coiling, endovascular balloon occlusion, flow diverterThe endovascular techniques that embolize the cavity of aneurysms to reduce the risk of rupture, including coiling embolization, balloon-assisted occlusion. | Procedure or surgery | Hybrid operation, Traditional therapy |
| carotid endarterectomyA microsurgical technique to recanalize the stenosis or occluded proximal segment of carotid artery. | Procedure or surgery | Hybrid operation, Traditional therapy |
Primary outcome
morbidity rate of peri-operative cerebral hemorrhagic events
Time frame: through study completion, an average of 1 year
the morbidity rate of cerebral hemorrhagic events, with significant neuro-image evidence, during the period of treatment, including SAH/ICH/IVH caused by IAs, and intracranial hemorrhages caused by interventions focusing on AIAS
morbidity rate of peri-operative cerebral ischemic events
Time frame: through study completion, an average of 1 year
the morbidity rate of cerebral ischemic events, with significant neuro-image evidence, during the period of treatment, including all cerebral infarctions caused by interventions focusing on IAs and AIAS.
4 secondary outcomes
Peri-operative mortality rate
Time frame: through study completion, an average of 1 year
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 Microsurgical aneurysmal operating techniques, endovascular techniques for cerebrovascular stenosis and endovascular techniques for intracranial aneurysms in people with Intracranial Aneurysm and Cerebrovascular Stenosis, 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 18 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 (86-010-67096523, liuxingju006@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morbidity rate of peri-operative cerebral hemorrhagic events (time frame: through study completion, an average of 1 year). 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?
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.