Acute STROke Complicating TAVI - Management and Outcomes

Stroke Clinical Trial

— ASTRO-TAVI  

Official title:

Management and Outcomes of Acute STROke Complicating Transcatheter Aortic Valve Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05241821
• Other study ID #: 0502-21
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: February 5, 2022

Study information

• Verified date: February 2022
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Periprocedural complications of trans catheter aortic valve implantation, and particularly the occurrence of stroke has a marked impact on survival and quality of life. The characteristics of periprocedural stroke complicating TAVI, and particularly of interventions aimed to treat stroke complicating TAVI have not been systematically described. We therefore aimed is to explore the incidence and characteristics of acute stroke complicating TAVI and to describe the safety and efficacy of emergent interventions to treat acute stroke complicating TAVI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: February 5, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• patients who have had a stroke within 30 days of TAVI

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Periprocedural Complication
• Stroke

Intervention

Procedure:
• Mechanical thrombectomy
Percutaneous intervention aimed to retrieve/treat clot affecting the cerebral circulation.

Drug:
• Thrombolytic Agent
Drug aimed to dissolve thrombus affecting the cerebral circulation

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	All cause death	1-year
Primary	Neurologic disability free survival	modified rankin score (mRS) 0/1	90 days
Secondary	Bleeding complications	Severe bleeding / life-threatening bleeding as defined by VARC2 criteria	30 days