Surgical Management of Complex Intracranial Aneurysms With Hybrid Operating Techniques (CIA-HOTs)

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.

Study Overview

• Status: Unknown
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Procedure: Hybrid Operating Techniques

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 Type: Interventional
• Enrollment (Anticipated): 258
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xingju Liu, MD; Phone Number: 86-15011476305; Email: liuxingju006@163.com
• Study Contact Backup: Name: Mingze Wang, MD; Phone Number: 86-13699290543; Email: wmz_01@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 0086
      • Recruiting
      • Beijing Tiantan Hospital Capital Medical University

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:

• 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.

Exclusion Criteria:

• >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.

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
Experimental: Hybrid operation group; Intervene with hybrid operating techniques, eg. microsurgical clipping+endovascular coiling or with the assistant of balloon occlusion.	Procedure: Hybrid Operating Techniques; 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.; Other Names: endovascular coiling; flow diverter; microsurgical clipping; microsurgical dissection; microsurgical wrapping; microsurgical isolation; balloon-assisted occlusion
Other: Traditional therapy group; The aneurysms will be executed by traditional procedure, including microsurgical clipping, endovascular coiling or stenting, etc.	Procedure: Hybrid Operating Techniques; 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.; Other Names: endovascular coiling; flow diverter; microsurgical clipping; microsurgical dissection; microsurgical wrapping; microsurgical isolation; balloon-assisted occlusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operation-related mortality rate	the mortality rate related to the operation	From the time of operation begin to 48 hours after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	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	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	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	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	the 12th month after operation, ±1 week
Treatment-related costs	All expenses cost in hospital relating to the aiming disease	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	through study completion, an average of 1 year
Duration of total operating time	Total operating time of all procedures, including operation, and DSA	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): April 1, 2016
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 29, 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 29, 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; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: BJTTH-004

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