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

Cerebrovascular Disease Clinical Trial

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

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03774017
Study type Interventional
Source Ministry of Science and Technology of the People´s Republic of China
Contact Shuo Wang, MD
Phone 861059976510
Email captain9858@vip.sina.com
Status Recruiting
Phase N/A
Start date January 1, 2016
Completion date December 31, 2020
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