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

Primary Purpose

Intracranial Aneurysm, Cerebrovascular Stenosis, Atheroscleroses, Cerebral

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Microsurgical aneurysmal operating techniques
endovascular techniques for cerebrovascular stenosis
endovascular techniques for intracranial aneurysms
carotid endarterectomy
Sponsored by
liuxingju
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysm

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Tiantan Hospital Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Traditional therapy

Hybrid operation

Arm Description

Consists of microsurgical aneurysmal operating techniques, endovascular techniques for intracranial aneurysms, endovascular techniques for cerebrovascular stenosis, and carotid endarterectomy, which are presented by stages.

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Peri-operative mortality rate
The mortality rate during the period of treatment
Treatment-related costs
The total in-patient expenses of the aiming diseases, covering all treating stages
Duration of hospitalization
The total hospitalizations for the treatment of aiming diseases, covering all treating stages
Duration of total operating time
The total operating time, the sum of durations of multi-stages operation if several procedures are presented

Full Information

First Posted
June 27, 2017
Last Updated
June 27, 2017
Sponsor
liuxingju
Collaborators
Beijing Municipal Science & Technology Commission
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1. Study Identification

Unique Protocol Identification Number
NCT03204435
Brief Title
Hybrid Operating Treatment of Coexistence of Intracranial Aneurysms and Cerebrovascular Stenosis
Acronym
HOT-CIACS
Official Title
Clinical Trail of Hybrid Operating Technique in Management of Intracranial Aneurysms With Coexistence of Atherosclerotic Intracranial Arterial Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
liuxingju
Collaborators
Beijing Municipal Science & Technology Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm, Cerebrovascular Stenosis, Atheroscleroses, Cerebral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional therapy
Arm Type
Other
Arm Description
Consists of microsurgical aneurysmal operating techniques, endovascular techniques for intracranial aneurysms, endovascular techniques for cerebrovascular stenosis, and carotid endarterectomy, which are presented by stages.
Arm Title
Hybrid operation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Microsurgical aneurysmal operating techniques
Other Intervention Name(s)
microsurgical aneurysmal clipping, microsurgical aneurysmal wrapping, microsurgical aneurysmal isolation
Intervention Description
The microsurgical techniques used to evacuate the aneurysm out of circulation or reduce its risk of rupture by aneurysmal clipping, wrapping,or isolation.
Intervention Type
Procedure
Intervention Name(s)
endovascular techniques for cerebrovascular stenosis
Other Intervention Name(s)
endovascular stenting, endovascular balloon dilatation
Intervention Description
The endovascular techniques that recanalize the narrowed or occluded cerebrovascular, including stent implantation, balloon dilatation.
Intervention Type
Procedure
Intervention Name(s)
endovascular techniques for intracranial aneurysms
Other Intervention Name(s)
endovascular coiling, endovascular balloon occlusion, flow diverter
Intervention Description
The endovascular techniques that embolize the cavity of aneurysms to reduce the risk of rupture, including coiling embolization, balloon-assisted occlusion.
Intervention Type
Procedure
Intervention Name(s)
carotid endarterectomy
Intervention Description
A microsurgical technique to recanalize the stenosis or occluded proximal segment of carotid artery.
Primary Outcome Measure Information:
Title
morbidity rate of peri-operative cerebral hemorrhagic events
Description
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
Time Frame
through study completion, an average of 1 year
Title
morbidity rate of peri-operative cerebral ischemic events
Description
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.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Peri-operative mortality rate
Description
The mortality rate during the period of treatment
Time Frame
through study completion, an average of 1 year
Title
Treatment-related costs
Description
The total in-patient expenses of the aiming diseases, covering all treating stages
Time Frame
through study completion, an average of 1 year
Title
Duration of hospitalization
Description
The total hospitalizations for the treatment of aiming diseases, covering all treating stages
Time Frame
through study completion, an average of 1 year
Title
Duration of total operating time
Description
The total operating time, the sum of durations of multi-stages operation if several procedures are presented
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xingju Liu, MD
Phone
86-010-67096523
Email
liuxingju006@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mingze Wang, MD
Phone
86-010-67096510
Email
wmz_01@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jizong Zhao, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Tiantan Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingju Liu, MD
Phone
86-010-670965423
Email
liuxingju003@163.com
First Name & Middle Initial & Last Name & Degree
Mingze Wang, MD
Phone
86-010-67096510
Email
wmz_01@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
the IPD will be open to public researchers in 6 months after the study closed

Learn more about this trial

Hybrid Operating Treatment of Coexistence of Intracranial Aneurysms and Cerebrovascular Stenosis

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