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Completed

NCT Number: NCT03209804

Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room

To evaluate the clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hybrid operating techniques

Procedure

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

Primary outcomes

  1. Instant residual rate of AVMs

    Time frame: up to 1 week after operation

    The instant post-operative residual rate of AVMs

  2. 3 months' residual rate of AVMs

    Time frame: the date of 3rd month after operation, ±1 week

    3 months' residual rate after AVM operation

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. Post-operative mortality rate

    Time frame: 48 hours after operation

    operation related mortality

  3. 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

  4. Morbidity rate of neural functional deterioration-1 week after operation

    Time frame: 1 week after operation

    The score of modified Rankin Scale increases ≥2

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

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

Other Gov

Collaborators

  • Beijing Municipal Science & Technology Commission

Registry information

Acronym: SMAVMHR

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jul 6, 2017
Registry last updated
Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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