Surgical Management of Complex Intracranial Aneurysms With Hybrid Operating Techniques

NCT03206853 | Unknown DMC

• 1 other identifier: BJTTH-004
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the clinical benefits and risks of hybrid operating techniques in management of complex intracranial aneurysms, which could coexists with multiple risk factors.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

• operation-related mortality rate

  the mortality rate related to the operation

  From the time of operation begin to 48 hours after operation

Secondary Outcomes (11)

• Morbidity rate of peri-operative intracranial hemorrhage

  From date of admission to the 7 days after operation

• Morbidity rate of peri-operative intracranial ischemic events

  From date of admission to 7 days after operation

• Residual rate of aneurysms

  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

  48 hours after operation, ±6 hours

• Morbidity rate of neural functional deterioration in 7 days

  7 days after operation, ±2 days

Study Arms (2)

Hybrid operation group

EXPERIMENTAL

Intervene with hybrid operating techniques, eg. microsurgical clipping+endovascular coiling or with the assistant of balloon occlusion.

Procedure: Hybrid Operating Techniques

Traditional therapy group

OTHER

The aneurysms will be executed by traditional procedure, including microsurgical clipping, endovascular coiling or stenting, etc.

Procedure: Hybrid Operating Techniques

Interventions

Hybrid Operating Techniques PROCEDURE

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.

Also known as: microsurgical clipping, microsurgical dissection, microsurgical wrapping, microsurgical isolation, endovascular coiling, balloon-assisted occlusion, flow diverter

Hybrid operation group; Traditional therapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \>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.

Sponsors & Collaborators

• liuxingju: lead
• Beijing Municipal Science & Technology Commission: collaborator

Study Sites (1)

Beijing Tiantan Hospital Capital Medical University

Beijing, Beijing Municipality, 0086, China

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jizong Zhao, MD

  Beijing Tiantan Hospital

  STUDY DIRECTOR

Central Study Contacts

Xingju Liu, MD

CONTACT

86-15011476305; liuxingju006@163.com

Mingze Wang, MD

CONTACT

86-13699290543; wmz_01@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Model Details: Traditional therapy group：the aneurysms will be executed by traditional procedure, including microsurgical clipping, endovascular coiling or stenting, etc. Hybrid operation group: Intervene with hybrid operating techniques, eg. microsurgical clipping+endovascular coiling or with the assistant of balloon occlusion.

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 2, 2017
• Study Start: April 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

CN (1)