Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room (SMAVMHR)

March 12, 2020 updated by: Shuo Wang, Ministry of Science and Technology of the People´s Republic of China
To evaluate the clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose: Have an evaluation of clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations(AVMs). Meanwhile, as a new cooperative interventional modality, optimized workflows, technical key knots and operation routines will be explored in the study.

Objects: Patients with cerebral arteriovenous malformations, 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. Residual rate of AVM is considered to be the primary observing indicator, and morbidity rate of post-operative complications, post-operative mortality rate, and morbidity rate of neural functional deterioration 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 (Actual)

519

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Beijing Hospital
      • Beijing, Beijing, China, 0086
        • Beijing Tiantan Hospital Capital Medical University
      • Beijing, Beijing, China, 100039
        • General Hospital of PLA
      • Beijing, Beijing, China, 100088
        • Rocket Army General Hospital of PLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • newly ruptured AVM with stable hematoma, selective operation is practical;
  • with rupture history;
  • recurrent epilepsy, failed in AED management;
  • giant AVM with deterioration of neurological functions;
  • 1-4 grade AVM (Spetzler-Martin grading system) with no symptom and not located in eloquent area.

Exclusion Criteria:

  • >70 in age, with low rupture risk;
  • newly ruptured AVM with unstable hematoma, engaged in emergency operation;
  • ≥5 grade in Spetzler-Martin grading system;
  • AVM located in hypothalamus, brainstem, cerebellopontine angle;
  • cannot tolerant the operation;
  • patient or relative refuses to participate the trail.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Traditional neurosurgical techniques
Unsimultaneous endovascular interventional embolisation/radiotherapy followed by microsurgical resection, as traditional clinical routines.
Procedure: hybrid operating techniques
A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.
Other Names:
  • endovascular interventional embolisation
  • endovascular interventional balloon occlusion
  • microsurgical resection
Experimental: Hybrid operating techniques
A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously
Procedure: hybrid operating techniques
A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.
Other Names:
  • endovascular interventional embolisation
  • endovascular interventional balloon occlusion
  • microsurgical resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Instant residual rate of AVMs
Time Frame: up to 1 week after operation
The instant post-operative residual rate of AVMs
up to 1 week after operation
3 months' residual rate of AVMs
Time Frame: the date of 3rd month after operation, ±1 week
3 months' residual rate after AVM operation
the date of 3rd month after operation, ±1 week
6 months' residual rate of AVMs
Time Frame: the date of the 6th month after operation, ±1 week
6 months' residual rate after AVM operation
the date of the 6th month after operation, ±1 week
1 year's residual rate of AVMs
Time Frame: the date of the 12th month after operation, ±1 week
1 year's residual rate after AVM operation
the date of the 12th month after operation, ±1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity rate of post-operative complications
Time Frame: 7 days after operation
Include intracranial hemorrhage or infarction, infection of central neural system, infection of respiratory system, cranial nerve deficits, and other symptomatic complications
7 days after operation
Post-operative mortality rate
Time Frame: 48 hours after operation
operation related mortality
48 hours after operation
Morbidity rate of neural functional deterioration-48 hours after operation
Time Frame: the assessing time points is 48 hours after operation
The score of modified Rankin Scale increases ≥2
the assessing time points is 48 hours after operation
Morbidity rate of neural functional deterioration-1 week after operation
Time Frame: 1 week after operation
The score of modified Rankin Scale increases ≥2
1 week after operation
Morbidity rate of neural functional deterioration-3 months after operation
Time Frame: the 3rd month after operation, ±1 week
The score of modified Rankin Scale increases ≥2
the 3rd month after operation, ±1 week
Morbidity rate of neural functional deterioration-6 months after operation
Time Frame: the 6th month after operation, ±1 week
The score of modified Rankin Scale increases ≥2
the 6th month after operation, ±1 week
Morbidity rate of neural functional deterioration-12 months after operation
Time Frame: the 12th month after operation, ±1 week
The score of modified Rankin Scale increases ≥2
the 12th month after operation, ±1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Science and Technology of the People´s Republic of China

Collaborators

Beijing Municipal Science & Technology Commission

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

January 16, 2020

Study Registration Dates

First Submitted

June 26, 2017

First Submitted That Met QC Criteria

July 3, 2017

First Posted (Actual)

July 6, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJTTH-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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