Hybrid Operating Treatment of Coexistence of Intracranial Aneurysms and Cerebrovascular Stenosis

NCT03204435 | Unknown DMC

• 1 other identifier: BJTTH-005
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Aneurysm; Cerebrovascular Stenosis; Atheroscleroses, Cerebral

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Peri-operative mortality rate

  through study completion, an average of 1 year

• Treatment-related costs

  through study completion, an average of 1 year

• Duration of hospitalization

  through study completion, an average of 1 year

• Duration of total operating time

  through study completion, an average of 1 year

Study Arms (2)

Traditional therapy

OTHER

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; Procedure: endovascular techniques for cerebrovascular stenosis; Procedure: endovascular techniques for intracranial aneurysms; Procedure: carotid endarterectomy

Hybrid operation

EXPERIMENTAL

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; Procedure: endovascular techniques for cerebrovascular stenosis; Procedure: endovascular techniques for intracranial aneurysms; Procedure: carotid endarterectomy

Interventions

Microsurgical aneurysmal operating techniques PROCEDURE

The microsurgical techniques used to evacuate the aneurysm out of circulation or reduce its risk of rupture by aneurysmal clipping, wrapping,or isolation.

Also known as: microsurgical aneurysmal clipping, microsurgical aneurysmal wrapping, microsurgical aneurysmal isolation

Hybrid operation; Traditional therapy

endovascular techniques for cerebrovascular stenosis PROCEDURE

The endovascular techniques that recanalize the narrowed or occluded cerebrovascular, including stent implantation, balloon dilatation.

Also known as: endovascular stenting, endovascular balloon dilatation

Hybrid operation; Traditional therapy

endovascular techniques for intracranial aneurysms PROCEDURE

The endovascular techniques that embolize the cavity of aneurysms to reduce the risk of rupture, including coiling embolization, balloon-assisted occlusion.

Also known as: endovascular coiling, endovascular balloon occlusion, flow diverter

Hybrid operation; Traditional therapy

carotid endarterectomy PROCEDURE

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

Hybrid operation; Traditional therapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• \>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

Sponsors & Collaborators

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

Study Sites (1)

Beijing Tiantan Hospital Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm; Intracranial Arteriosclerosis

Interventions

Endovascular Procedures; Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Endarterectomy

Study Officials

• Jizong Zhao, MD

  Beijing Tiantan Hospital

  STUDY DIRECTOR

Central Study Contacts

Xingju Liu, MD

CONTACT

86-010-67096523; liuxingju006@163.com

Mingze Wang, MD

CONTACT

86-010-67096510; 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: 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.

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 2, 2017
• Study Start: June 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)