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

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.

Study Overview

• Status: Unknown
• Conditions: Intracranial Aneurysm; Atheroscleroses, Cerebral; Cerebrovascular Stenosis
• Intervention / Treatment: Procedure: Microsurgical aneurysmal operating techniques; Procedure: endovascular techniques for cerebrovascular stenosis; Procedure: endovascular techniques for intracranial aneurysms; Procedure: carotid endarterectomy

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 Type: Interventional
• Enrollment (Anticipated): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Tiantan Hospital Capital Medical University
      • Contact: Mingze Wang, MD; Phone Number: 86-010-67096510; Email: wmz_01@sina.com
      • Contact: Xingju Liu, MD; Phone Number: 86-010-670965423; Email: liuxingju003@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-operative mortality rate	The mortality rate during the period of treatment	through study completion, an average of 1 year
Treatment-related costs	The total in-patient expenses of the aiming diseases, covering all treating stages	through study completion, an average of 1 year
Duration of hospitalization	The total hospitalizations for the treatment of aiming diseases, covering all treating stages	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	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: liuxingju
• Collaborators: Beijing Municipal Science & Technology Commission
• Investigators: Study Director: Jizong Zhao, MD, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Intracranial Arterial Diseases; Constriction, Pathologic; Atherosclerosis; Aneurysm; Intracranial Aneurysm; Intracranial Arteriosclerosis
• Other Study ID Numbers: BJTTH-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: the IPD will be open to public researchers in 6 months after the study closed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No