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Hybrid Operating Treatment of Coexistence of Intracranial Aneurysms and Cerebrovascular Stenosis (HOT-CIACS)

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ClinicalTrials.gov Identifier: NCT03204435
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
liuxingju, Ministry of Science and Technology of the People´s Republic of China

Brief Summary:
To evaluate the clinical benefits and risks of hybrid operating techniques in management of intracranial aneurysms with coexistence of atherosclerotic intracranial arterial stenosis.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Cerebrovascular Stenosis Atheroscleroses, Cerebral Procedure: Microsurgical aneurysmal operating techniques Procedure: endovascular techniques for cerebrovascular stenosis Procedure: endovascular techniques for intracranial aneurysms Procedure: carotid endarterectomy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trail of Hybrid Operating Technique in Management of Intracranial Aneurysms With Coexistence of Atherosclerotic Intracranial Arterial Stenosis
Actual Study Start Date : June 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Traditional therapy
Consists of microsurgical aneurysmal operating techniques, endovascular techniques for intracranial aneurysms, endovascular techniques for cerebrovascular stenosis, and carotid endarterectomy, which are presented by stages.
Procedure: Microsurgical aneurysmal operating techniques
The microsurgical techniques used to evacuate the aneurysm out of circulation or reduce its risk of rupture by aneurysmal clipping, wrapping,or isolation.
Other Names:
  • microsurgical aneurysmal clipping
  • microsurgical aneurysmal wrapping
  • microsurgical aneurysmal isolation

Procedure: endovascular techniques for cerebrovascular stenosis
The endovascular techniques that recanalize the narrowed or occluded cerebrovascular, including stent implantation, balloon dilatation.
Other Names:
  • endovascular stenting
  • endovascular balloon dilatation

Procedure: endovascular techniques for intracranial aneurysms
The endovascular techniques that embolize the cavity of aneurysms to reduce the risk of rupture, including coiling embolization, balloon-assisted occlusion.
Other Names:
  • endovascular coiling
  • endovascular balloon occlusion
  • flow diverter

Procedure: carotid endarterectomy
A microsurgical technique to recanalize the stenosis or occluded proximal segment of carotid artery.

Experimental: Hybrid operation
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.
Procedure: Microsurgical aneurysmal operating techniques
The microsurgical techniques used to evacuate the aneurysm out of circulation or reduce its risk of rupture by aneurysmal clipping, wrapping,or isolation.
Other Names:
  • microsurgical aneurysmal clipping
  • microsurgical aneurysmal wrapping
  • microsurgical aneurysmal isolation

Procedure: endovascular techniques for cerebrovascular stenosis
The endovascular techniques that recanalize the narrowed or occluded cerebrovascular, including stent implantation, balloon dilatation.
Other Names:
  • endovascular stenting
  • endovascular balloon dilatation

Procedure: endovascular techniques for intracranial aneurysms
The endovascular techniques that embolize the cavity of aneurysms to reduce the risk of rupture, including coiling embolization, balloon-assisted occlusion.
Other Names:
  • endovascular coiling
  • endovascular balloon occlusion
  • flow diverter

Procedure: carotid endarterectomy
A microsurgical technique to recanalize the stenosis or occluded proximal segment of carotid artery.




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Peri-operative mortality rate [ Time Frame: through study completion, an average of 1 year ]
    The mortality rate during the period of treatment

  2. Treatment-related costs [ Time Frame: through study completion, an average of 1 year ]
    The total in-patient expenses of the aiming diseases, covering all treating stages

  3. Duration of hospitalization [ Time Frame: through study completion, an average of 1 year ]
    The total hospitalizations for the treatment of aiming diseases, covering all treating stages

  4. Duration of total operating time [ Time Frame: through study completion, an average of 1 year ]
    The total operating time, the sum of durations of multi-stages operation if several procedures are presented



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;
  • <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.

Exclusion Criteria:

  • >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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204435


Contacts
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Contact: Xingju Liu, MD 86-010-67096523 liuxingju006@163.com
Contact: Mingze Wang, MD 86-010-67096510 wmz_01@sina.com

Locations
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China, Beijing
Beijing Tiantan Hospital Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Xingju Liu, MD    86-010-670965423    liuxingju003@163.com   
Contact: Mingze Wang, MD    86-010-67096510    wmz_01@sina.com   
Sponsors and Collaborators
liuxingju
Beijing Municipal Science & Technology Commission
Investigators
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Study Director: Jizong Zhao, MD Beijing Tiantan Hospital

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Responsible Party: liuxingju, Researcher, Ministry of Science and Technology of the People´s Republic of China
ClinicalTrials.gov Identifier: NCT03204435     History of Changes
Other Study ID Numbers: BJTTH-005
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: the IPD will be open to public researchers in 6 months after the study closed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Brain Diseases
Constriction, Pathologic
Atherosclerosis
Intracranial Arteriosclerosis
Pathological Conditions, Anatomical
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases