Hybrid Operating Treatment of Coexistence of Intracranial Aneurysms and Cerebrovascular Stenosis

Intracranial Aneurysm Clinical Trial

— HOT-CIACS  

Official title:

Clinical Trail of Hybrid Operating Technique in Management of Intracranial Aneurysms With Coexistence of Atherosclerotic Intracranial Arterial Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03204435
• Other study ID #: BJTTH-005
• Status: Recruiting
• Phase: N/A
• First received: June 27, 2017
• Last updated: June 27, 2017
• Start date: June 2016
• Est. completion date: December 2019

Study information

• Verified date: June 2017
• Source: Ministry of Science and Technology of the People´s Republic of China
• Contact: Xingju Liu, MD
• Phone: 86-010-67096523
• Email: liuxingju006[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Atheroscleroses, Cerebral
• Atherosclerosis
• Cerebrovascular Stenosis
• Constriction, Pathologic
• Intracranial Aneurysm
• Intracranial Arteriosclerosis

Intervention

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.
• endovascular techniques for cerebrovascular stenosis
The endovascular techniques that recanalize the narrowed or occluded cerebrovascular, including stent implantation, balloon dilatation.
• 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.
• carotid endarterectomy
A microsurgical technique to recanalize the stenosis or occluded proximal segment of carotid artery.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
liuxingju	Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion, an average of 1 year
Primary	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.	through study completion, an average of 1 year
Secondary	Peri-operative mortality rate	The mortality rate during the period of treatment	through study completion, an average of 1 year
Secondary	Treatment-related costs	The total in-patient expenses of the aiming diseases, covering all treating stages	through study completion, an average of 1 year
Secondary	Duration of hospitalization	The total hospitalizations for the treatment of aiming diseases, covering all treating stages	through study completion, an average of 1 year
Secondary	Duration of total operating time	The total operating time, the sum of durations of multi-stages operation if several procedures are presented	through study completion, an average of 1 year