Acute STROke Complicating TAVI - Management and Outcomes | NCT05241821

Studies
Acute STROke Complicating TAVI - Management and Outcomes

NCT05241821

Sponsor

Rabin Medical Center

Status

Completed

Last Update Posted

Feb 16, 2022Actual

Enrollment

484Actual

Phase

Not provided

Conditions

Stroke
Aortic Valve Stenosis
Periprocedural Complication

Interventions

Mechanical thrombectomy
Thrombolytic Agent

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Jan 31, 2022Actual

Completion Date

Feb 5, 2022Actual

First Submitted Date

Feb 5, 2022

First Submission Date that Met QC Criteria

Feb 5, 2022

First Posted Date

Feb 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2022

Last Update Posted Date

Feb 16, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

484Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conservative treatment		patients with periprocedural stroke after TAVI, treated conservatively
Neuro-intervention		patients with periprocedural stroke after TAVI, treated with neuro-intervention	Procedure: Mechanical thrombectomy Drug: Thrombolytic Agent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mechanical thrombectomy	Procedure	Percutaneous intervention aimed to retrieve/treat clot affecting the cerebral circulation.	Neuro-intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All cause mortality	All cause death	1-year
Neurologic disability free survival	modified rankin score (mRS) 0/1	90 days

Secondary Outcomes

Measure	Description	Time Frame
Bleeding complications	Severe bleeding / life-threatening bleeding as defined by VARC2 criteria	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who have had a stroke within 30 days of TAVI

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with periprocedural stroke complicating TAVI

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ran Kornowski, MD	Head of cardiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rabin Medical Center		Petah Tikva			Israel

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005343	Fibrinolytic Agents

Ancestor Terms

ID	Term
D050299	Fibrin Modulating Agents
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided