Is Total Arterial Revascularization Superior to Multiarte... | NCT06766084

Studies
Is Total Arterial Revascularization Superior to Multiarterial Grafting in Coronary Artery Bypass Grafting

NCT06766084

Sponsor

Technion, Israel Institute of Technology

Status

Completed

Last Update Posted

Jan 9, 2025Actual

Enrollment

7,878Actual

Phase

Not provided

Conditions

CABG
Revascularization

Interventions

CABG

Countries

Not provided

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

Jan 2025

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

Jan 1, 2009Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Jan 2, 2025

First Submission Date that Met QC Criteria

Jan 8, 2025

First Posted Date

Jan 9, 2025Actual

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

Jan 8, 2025

Last Update Posted Date

Jan 9, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dror B. Leviner, Director of advanced cardiac surgery Department of cardiac surgery Carmel medical center, Technion, Israel Institute of TechnologyPrincipal Investigator

Lead Sponsor

Technion, Israel Institute of TechnologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Retrospective study of adult patients with multivessel disease undergoing isolated coronary artery bypass grafting (CABG) in three centers between January 1st, 2009, and December 31st, 2023. Patients were grouped according to the revascularization strategy (total arterial revascularization vs. multiarterial grafting). Primary outcome was a composite of major adverse cardiac and cerebrovascular events (MACCE).

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

7,878Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
multiarterial grafting			Procedure: CABG
total arterial revascularization			Procedure: CABG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CABG	Procedure	All patients underwent isolated CABG and retrospectively followed to asses clinical outcomes of the two different revascularization techniques	multiarterial grafting

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MACCE		through study completion, a median of 101 months

Secondary Outcomes

Measure	Description	Time Frame
Mortality		through study completion, a median of 101 months
MI		through study completion, a median of 101 months
CVA

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

isolated CABG

Exclusion Criteria:

single vessel CABG
CABG with utilization of only one arterial graft

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients undergoing isolated CABG at Carmel medical center, Beilinson medical center and Soroka medical center at Israel

Sampling Method

Non-Probability Sample