OUTCOME AND SAFETY OF RECANALIZATION TREATMENTS IN ISCHEMIC STROKE DUE TO ACUTE BASILAR ARTERY OCCLUSION

NCT05402878 | Unknown

• 1 other identifier: People 115 Hospital
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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). 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. 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.

Conditions

Basilar Artery Occlusion

Keywords

BASILAR ARTERY OCCLUSION; RECANALISATION THERAPY

Outcome Measures

Primary Outcomes (1)

• favourable outcome

  a modified Rankin Score of 0-3

  90 (± 14 days) after procedure

Secondary Outcomes (6)

• good outcome

  90 (± 14 days) after procedure

• mortality

  90 (± 14 days) after procedure

• Dichotomized mRS score

  90 (± 14 days) after procedure

• Symptomatic intracerebral hemorrhage (sICH)

  within 72 hours after procedure

• Any intracerebral hemorrhage

  within 72 hours after procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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..

You may not qualify if:

• Patients did not agree to enroll.
• High-density lesion consistent with hemorrhage of any degree
• Significant cerebellar mass effect or acute hydrocephalus

Sponsors & Collaborators

• 115 People's Hospital: lead

Study Sites (1)

People 115 Hospital

Ho Chi Minh City, Ho Chi Minh City, 70000, Vietnam

RECRUITING

Study Officials

• Huy Thang Nguyen, Professor

  People 115 Hospital

  STUDY DIRECTOR

Central Study Contacts

Bich Huong Nguyen

CONTACT

+84989689525; bichhuong.medic@gmail.com

Huy Thang Nguyen

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 2, 2022
• Study Start: August 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 26, 2022

Record last verified: 2022-07

Locations

VN (1)