Status:
UNKNOWN
Research on Hybrid Operation Technique in the Treatment of Complex Brain Arteriovenous Malformations
Lead Sponsor:
Ministry of Science and Technology of the People´s Republic of China
Conditions:
Cerebrovascular Disease
Arteriovenous Malformations
Eligibility:
All Genders
Up to 70 years
Phase:
NA
Brief 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 operatio...
Detailed 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...
Eligibility Criteria
Inclusion
- patients of all ages;
- diagnosed with arteriovenous malformations (AVMs) in brain parenchyma (including cerebrum and cerebellum) by DSA, with/without dura arteriovenous fistula;
- 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;
- with Spetzler-Martin Grades from I to IV;
- who provide informed consent.
Exclusion
- \>70 years old with no significant hemorrhagic risk of bAVMs;
- with Spetzler-Martin Grade ≥V;
- accompanied by severe chronic disease, organ dysfunction, or malignant tumor that cannot tolerate the operation;
- allergic to iodinated contrast agent;
- unable to give informed consent.
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT03774017
Start Date
January 1 2016
End Date
December 31 2020
Last Update
December 12 2018
Active Locations (7)
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1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053
2
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100070
3
General Hospital of Rocket Army
Beijing, Beijing Municipality, China, 100088
4
Qilu Hospital, Shandong University
Jinan, Shandong, China, 250012