Basilar Artery OcclusionNCT05402878
OUTCOME AND SAFETY OF RECANALIZATION TREATMENTS IN ISCHEMIC STROKE DUE TO ACUTE BASILAR ARTERY OCCLUSION
An observational study of Basilar Artery Occlusion, run by 115 People's Hospital at 1 site in Vietnam.
Trial summary
Rationale: Recently, two prospective multicenter RCT reported a potential beneficial effect of endovascular thrombectomy (EVT) in patients with an acute symptomatic basilar artery occlusion (BAO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basilar Artery Occlusion
- How many people
- 150 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Aug 2021to 31 Dec 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who were acute ischemic stroke due to basilar artery occlusion admitted People 115 Hospital and treated recanalisation therapies : intravenous tPA, bridging tPA and thrombectomy or thrombectomy alone.
Who may be able to join
- Symptoms and signs compatible with ischemia in the basilar artery territory.
- Basilar artery occlusion (BAO) confirmed by CTA or MRA or DSA.
- Age 18 years or older
- Patients were treated with one of these among therapies IVT alone, bridging IVT and thrombectomy or thrombectomy alone..
Who cannot join
- Patients did not agree to enroll.
- Imaging exclusion criteria:
- High-density lesion consistent with hemorrhage of any degree
- Significant cerebellar mass effect or acute hydrocephalus
Trial locations and contacts
1 site in 1 country.
Huy Thang Nguyen contact
Vietnam1 site, 1 recruiting
- Recruiting
People 115 Hospital
Ho Chi Minh City, Ho Chi Minh City, 70000
Bich Huong Nguyen, +84989689525, bichhuong.medic@gmail.com
About this study
Official title: RECANALISATION THERAPY IN ISCHEMIC STROKE DUE TO BASILAR ARTERY OCCLUSION IN PEOPLE 115 HOSPITAL, VIETNAM
Rationale: Recently, two prospective multicenter RCT reported a potential beneficial effect of endovascular thrombectomy (EVT) in patients with an acute symptomatic basilar artery occlusion (BAO). However, the high rate of crossover in BEST study and the long-term of recruitment in BASICS study influenced the validity of the results.
Objective: To assess the outcomes and prognostic factors of recanalization therapy in patients with BAO, caused by a CTA/MRA/DSA confirmed occlusion of the basilar artery.
Read more
Study design: This is a prospective observational study. Study population: Patients with acute ischemic stroke and a confirmed basilar artery occlusion by CTA/MRA/DSA.
Main study parameters/outcomes: Favorable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3. The estimate will be adjusted for the known prognostic variables age, time from onset to treatment, stroke severity (NIHSS), PC ASPECT and collateral flow and adjusted and unadjusted estimates with corresponding 95% confidence intervals will be reported.
Read the detailed description
Acute basilar artery thrombosis is associated with a poor prognosis. Prevalence of basilar artery occlusion are not known in Vietnam.Various treatments were tried in groups of patients with acute ischemic stroke due to basilar artery occlusion, but evidence based was not cleared previous studies. Therefore, we conduct this study to evaluate the efficacy and safety of recanalization therapies, which included intravenous thrombosis alone, endovascular alone, or bridging IVT and endovascular, in basilar artery occlusion stroke patients.
- Conditions
- Basilar Artery Occlusion
- Keywords
- BASILAR ARTERY OCCLUSION, RECANALISATION THERAPY
What is being measured
The primary outcome is the main question the study is designed to answer.
favourable outcome
a modified Rankin Score of 0-3
Measured: 90 (± 14 days) after procedure
Secondary outcomes (6)
good outcome
a modified Rankin Score of 0-2
Measured: 90 (± 14 days) after procedure
mortality
Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100%.
Measured: 90 (± 14 days) after procedure
Dichotomized mRS score
mRS (0-2 versus 3-6 and 0-4 versus 5-6 )
Measured: 90 (± 14 days) after procedure
Symptomatic intracerebral hemorrhage (sICH)
SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 72 hours or any hemorrhage leading to death.
Measured: within 72 hours after procedure
Any intracerebral hemorrhage
intracerebral hemorrhage was defined according ECASS definition.
Measured: within 72 hours after procedure
Procedural related complications
arterial perforation, arterial dissection, embolization in a previously uninvolved vascular territory and so on
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Aug 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basilar Artery OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- 115 People's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, NGUYEN THI BICH HUONG, 115 People's Hospital
- Investigators
- Huy Thang Nguyen, Professor, Study director, People 115 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402878
- Sponsor's protocol ID
- People 115 Hospital
- Status last verified
- Jul 2022
- First submitted
- 26 May 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided