Research on Hybrid Operation Technique in the Treatment of Complex Brain Arteriovenous Malformations

Cerebrovascular Disease Clinical Trial

— HOTAVM  

Official title:

Study on Benefits and Risks of Hybrid Operation in the Treatment of Complex Brain Arteriovenous Malformations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03774017
• Other study ID #: BJTTH-007
• Secondary ID: 2016YFC1301801
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2018
• Source: Ministry of Science and Technology of the People´s Republic of China
• Contact: Shuo Wang, MD
• Phone: 861059976510
• Email: captain9858[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Complex brain arteriovenous malformations (bAVMs) in ≥3 Spetzler-Martin grades have long been challenges among cerebrovascular diseases. None of the traditional methods, such as microsurgical operation, endovascular intervention, or stereotactic radiotherapy, can completely eliminate complex bAVMs without a risk of neural function deterioration. The multistaged hybrid operation solved part of the challenge but remained risky in the installment procedures and intervals. The one-staged hybrid operation was applied in the surgical treatment of cerebrovascular diseases and proved to be a potentially safe and effective method for curing complex bAVMs. However, lacking the support of high-level evidence, its advantages remain unclear. This study was proposed to validate the benefits and risks of one-staged hybrid operation in the treatment of complex bAVMs, as well as its indications, key technologies, and workflows.

Description:

The study is being conducted from Jan 2016 to Dec 2020 with 20 cooperation units. It consists of 2 sets. The registry set is designed as a prospective real-world registry. The trial set is designed as a prospective pragmatic clinical trial, specifically for the patients with perforating arterial feeders. The two sets share a common grouping: the traditional operation group and the one-staged hybrid operation group. The assignment is based on the clinical condition in the registry set and is randomized in the trial set. End points will be evaluated at scheduled time points. The safety and efficiency of one-staged hybrid operation in treating complex bAVMs will be validated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

Inclusion Criteria:

1. patients of all ages;

2. diagnosed with arteriovenous malformations (AVMs) in brain parenchyma (including cerebrum and cerebellum) by DSA, with/without dura arteriovenous fistula;

3. with any operative indications as follows: (1) with stable hematoma or history of hemorrhage due to bAVMs, and allowed selective operation; (2) with recurrent epilepsy seizure, having failed treatment with antiepileptic drugs (AEDs); (3) with induced deterioration of neurological functions;

4. with Spetzler-Martin Grades from I to IV;

5. who provide informed consent.

Exclusion Criteria:

1. >70 years old with no significant hemorrhagic risk of bAVMs;

2. with Spetzler-Martin Grade =V;

3. accompanied by severe chronic disease, organ dysfunction, or malignant tumor that cannot tolerate the operation;

4. allergic to iodinated contrast agent;

5. unable to give informed consent.

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Cerebrovascular Disease
• Cerebrovascular Disorders
• Complex; Primary
• Congenital Abnormalities
• Hemangioma

Intervention

Procedure:
• one-staged hybrid operation
An integrated procedure that consists of microsurgery, intraoperative DSA, endovascular intervention techniques and other assistance tools. All the procedures are performed in a one-staged operation without any intermission or any transfer of patients.
• Traditional microsurgical operation
The classical mode of operations in neurosurgery. The operation is performed with neurosurgical instruments and microscope. Some of assisting tools can be used in the operation, such as neuro-navigation, Doppler probe, neural electrophysiological monitoring and so on. But neither the intraoperative DSA nor endovascular intervention techniques is used in the operation

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital Capital Medical University	Beijing	Beijing
China	General Hospital of Rocket Army	Beijing	Beijing
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Qilu Hospital, Shandong University	Jinan	Shandong
China	Qingdao Municipal Hospital	Qingdao	Shandong
China	Huashan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neural function deterioration	Increasing of mRS and mRS>2	3 months after operation
Secondary	neural function deterioration in 6 months	Increasing of mRS and mRS>2	6 months after operation
Secondary	neural function deterioration in 12 months	Increasing of mRS and mRS>2	12 months after operation
Secondary	postoperative mortality	the fatality due to operation	7 days after operation
Secondary	operation-related complications	any complications that occur within 7 days from the date of operation, including intracranial hemorrhage or infarction, infection of the central nervous system, infection of the respiratory system, cranial nerve deficits, and other symptomatic complications	7 days after operation
Secondary	postoperative bAVMs residue	the bAVMs residue revealed by postoperative DSA or computed tomographic angiography	7 days after operation
Secondary	3 months bAVMs residue	the bAVMs residue revealed by postoperative DSA or computed tomographic angiography	3 months after operation
Secondary	6 months bAVMs residue	the bAVMs residue revealed by postoperative DSA or computed tomographic angiography	6 months after operation
Secondary	12 months bAVMs residue	the bAVMs residue revealed by postoperative DSA or computed tomographic angiography	12 months after operation