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NCT03774017: HOTAVM

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

Status unknown NA Last updated 12 December 2018
What this trial tests

NA trial testing one-staged hybrid operation in Cerebrovascular Disease in 1,200 participants. Status unknown.

Timeline
1 January 2016
Primary endpoint
1 October 2020
31 December 2020

Quick facts

Lead sponsorMinistry of Science and Technology of the People´s Republic of China
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment1,200
Start date1 January 2016
Primary completion1 October 2020
Estimated completion31 December 2020
Sites7 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

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

Who can join

Under 70, any sex, with Cerebrovascular Disease or Arteriovenous Malformations. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. One-staged in situ embolization combined with surgical resection for eloquence protection of AVM: technical note.
    Wang M, Qiu H, Cao Y, Wang S, et al · · 2019 · cited 13× · PMID 31359304 · DOI 10.1007/s10143-019-01137-w
  2. Multimodal treatments of brain arteriovenous malformations: a comparison of microsurgical timings after endovascular embolization.
    Zeng C, Wang M, Song X, Zhang C, et al · · 2022 · cited 8× · PMID 35957722 · DOI 10.21037/atm-22-811
  3. State of the Art in the Role of Endovascular Embolization in the Management of Brain Arteriovenous Malformations-A Systematic Review.
    Pinkiewicz M, Pinkiewicz M, Walecki J, Zawadzki M. · · 2022 · cited 7× · PMID 36498782 · DOI 10.3390/jcm11237208
  4. Multimodality Treatment of Brain Arteriovenous Malformations with One-Staged Hybrid Operation: Clinical Characteristics and Long-Term Prognosis.
    Jiang Y, Zeng C, Zhang Y, Xu X, et al · · 2022 · cited 6× · PMID 35265225 · DOI 10.1155/2022/2559004
  5. Surgical management of complex brain arteriovenous malformations with hybrid operating technique: study protocol of a prospective registry and a pragmatic clinical trial.
    Wang M, Jiao Y, Cao Y, Wang S, et al · · 2019 · cited 6× · PMID 31039755 · DOI 10.1186/s12883-019-1289-3
  6. Comparison of Endovascular Embolization Plus Simultaneous Microsurgical Resection vs. Primary Microsurgical Resection for High-Grade Brain Arteriovenous Malformations.
    Wang M, Lin F, Qiu H, Cao Y, et al · · 2021 · cited 5× · PMID 35002920 · DOI 10.3389/fneur.2021.756307
  7. Emergency neurosurgical hybrid operating platform for acute intracranial hemorrhage (E-HOPE).
    Wang M, Ge P, Jiao Y, Deng X, et al · · 2024 · PMID 39676158 · DOI 10.1186/s41016-024-00385-0

Verify or expand the search:

Other recruiting trials for Cerebrovascular Disease

Currently open trials in the same condition.

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

Trials by the same sponsor.

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Data sources for this page

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