Status:
NOT_YET_RECRUITING
Treatment of Persistent Distal Occlusion After Successful Proximal Recanalization in Thrombectomy
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Stroke, Acute Thrombotic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In stroke patients, mechanical thrombectomy is now the standard of care when the stroke is due to large proximal cerebral vessel occlusion. The purpose of the 2BE3 trial is to test whether adjunct res...
Detailed Description
The purpose of the 2BE3 trial is to provide a clinical trial context for the use of rescue therapy (mechanical or pharmacological therapies) in patients with persistent distal occlusions after treatme...
Eligibility Criteria
Inclusion
- any patient with a large vessel occlusion in the M1 or M2 segment of the MCA (Middle Cerebral Artery), supraclinoid ICA (Internal Carotid Artery), or basilar artery who is a candidate for thrombectomy
- with a persistent distal occlusion in M2-M4, A1-A5, P1-P5 after successful recanalization of the proximal clot with mechanical thrombectomy and/or IV thrombolysis
Exclusion
- poor 3 month prognosis from comorbidities
- evidence of active bleeding on examination
- recent surgery with a significant risk of bleeding
- VKA (Vitamin K Antagonists) oral anticoagulation with INR (International Normalized Ratio) - \> 1.7
- curative heparin or direct oral anticoagulants in previous 48 hours
- platelet count \< 100 000/mm3
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06034847
Start Date
September 1 2024
End Date
January 1 2029
Last Update
August 15 2024
Active Locations (1)
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1
CHUM - Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 0A9