Clinical trial NCT03204435: Hybrid Operating Treatment of Coexistence of Intracranial Aneurysms and Cerebrovascular Stenosis
Official title: Clinical Trail of Hybrid Operating Technique in Management of Intracranial Aneurysms With Coexistence of Atherosclerotic Intracranial Arterial Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Aneurysm
Cerebrovascular Stenosis
Atheroscleroses, Cerebral
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2017-07-02
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: morbidity rate of peri-operative cerebral hemorrhagic events
timeFrame: through study completion, an average of 1 year
measure: morbidity rate of peri-operative cerebral ischemic events
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Peri-operative mortality rate
timeFrame: through study completion, an average of 1 year
measure: Treatment-related costs
timeFrame: through study completion, an average of 1 year
measure: Duration of hospitalization
timeFrame: through study completion, an average of 1 year
measure: Duration of total operating time
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Jizong Zhao, MD
role: STUDY_DIRECTOR
References: