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NCT03774017: HOTAVM
Research on Hybrid Operation Technique in the Treatment of Complex Brain Arteriovenous Malformations
NA trial testing one-staged hybrid operation in Cerebrovascular Disease in 1,200 participants. Status unknown.
1 October 2020
Quick facts
| Lead sponsor | Ministry of Science and Technology of the People´s Republic of China |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 1,200 |
| Start date | 1 January 2016 |
| Primary completion | 1 October 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 7 locations across China |
Drugs / interventions tested
- one-staged hybrid operation
- Traditional microsurgical operation
Conditions studied
- Cerebrovascular Disease — all drugs for Cerebrovascular Disease →
- Arteriovenous Malformations — all drugs for Arteriovenous Malformations →
- Complex; Primary — all drugs for Complex; Primary →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT03774017
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03774017 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ministry of Science and Technology of the People´s Republic of China
- Last refreshed: 12 December 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03774017.
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