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Efficacy and Safety of One-Stage Hybrid Coronary Revascularization (HCR-EAST)

Primary Purpose

Multivessel Coronary Artery Disease

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

coronary revascularization

About this trial

This is an interventional treatment trial for Multivessel Coronary Artery Disease focused on measuring hybrid coronary revascularization (HCR), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), multivessel coronary artery disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 Years and older
signed the informed consent
indicated for revascularization, with possible bypass segment in LAD and amendable lesions by PCI in other vessels
anatomy requiring as following: (1) Multivessel CAD involving the LAD (proximal or mid) and/or LM (ostial, mid-shaft or distal) with at least 1 other epicardial coronary artery requiring treatment in LCX or RCA, including: (2) LAD disease, and a major diagonal lesion, either bifurcation or independent in location, with both requiring revascularization (determined by QFR or FFR) (3) LM distal bifurcation lesion (Medina 1,1,1), intended for 2-stent approach if randomized to PCI
Heart team discussion after angiogram, with conclusion of suitable candidate for either PCI or HCR
Able to tolerate and no plans to interrupt dual anti-platelet therapy for 3~12 months
Willing to comply with 2-year clinical follow-up

Exclusion Criteria:

Previous cardiac or thoracic surgery
Previous PCI of the LM and/or LAD within 12 months
Totally occluded left main vessel
Cardiogenic shock or LVEF <30%
Previous STEMI within 30-day prior to randomization
Concomitant vascular or other cardiac disease with plan of surgical treatment
Indication for chronic oral anticoagulation therapy
Previous stroke history within 6-month prior to randomization
Survival expectation less than 3 years due to non-cardiac illness
Allergy or hypersensitivity to any of the study drugs or devices used in the trial
Enrolled in additional clinical study
Informed consent not available or noncompliance with follow-up
Pregnant

Sites / Locations

Shanghai East HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

one-step Hybrid Coronary Revascularization (HCR)

Percutaneous Coronary Intervention (PCI)

Arm Description

One-step HCR is defined as off-pump MIDCAB LIMA-LAD revascularization immediately followed by PCI for at-least one non-LAD lesion(or LAD-diagonal lesion) with DES implantation in a hybrid operating room.

PCI will be performed using standard technique at the discretion of interventional cardiologist with DES implantation in a routine catheter lab.

Outcomes

Primary Outcome Measures

Major Adverse Cardiac and Cerebrovascular Events (MACCE)

the occurrence of MACCE at 2 years' clinical follow-up, including all-cause death, myocardial infarction, stroke, and repeated revascularization

Secondary Outcome Measures

Bleeding events

individual component of MACCE

Hospital duration (day)

Rate of complete revascularization at index hospitalization

rate of complete revascularization at index hospitalization (defined by Quantitative flow ration[QFR] or Fraction flow reserve[FFR])

Stent thrombosis event

stent thrombosis defined by Academic Research Consortium (ARC)

Full Information

NCT ID

NCT04811586

First Posted

March 18, 2021

Last Updated

March 22, 2021

Sponsor

Shanghai East Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04811586

Brief Title

Efficacy and Safety of One-Stage Hybrid Coronary Revascularization

Acronym

HCR-EAST

Official Title

Efficacy and Safety of One-Step Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention for Patients With Multivessel Disease

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Recruiting

Study Start Date

December 30, 2020 (Actual)

Primary Completion Date

December 1, 2021 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai East Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Coronary revascularization could be accomplished either by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). PCI with drug-eluting stent (DES) implantation is featured by minimal invasive, low complication and rapid rehabilitation. CABG is characterized by improved long-term, event-free survival attributable to the use of left internal mammary artery (LIMA) graft. Hybrid coronary revascularization (HCR) consists of LIMA bypass to left anterior coronary descending artery (LAD) by minimal invasive direct coronary artery bypass (MIDCAB) and PCI of other stenosed coronary arteries with DES implantation. One-step HCR entails LIMA-LAD anastomosis performed through MIDCAB, immediately followed by PCI for non-LAD lesions, sometimes for diagonal branch, in the hybrid operating room. Limited data are available in comparing one-step HCR to PCI alone for the treatment of multivessel coronary artery disease(MVD). The current EAST-HCR study will investigate the efficacy and safety of one-step HCR for patients with MVD, as comparing to PCI alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multivessel Coronary Artery Disease

Keywords

hybrid coronary revascularization (HCR), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), multivessel coronary artery disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

one-step Hybrid Coronary Revascularization (HCR)

Arm Type

Experimental

Arm Description

Arm Title

Percutaneous Coronary Intervention (PCI)

Arm Type

Active Comparator

Arm Description

PCI will be performed using standard technique at the discretion of interventional cardiologist with DES implantation in a routine catheter lab.

Intervention Type

Procedure

Intervention Name(s)

coronary revascularization

Intervention Description

to improve the blood supply for coronary arteries by using either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)

Primary Outcome Measure Information:

Title

Major Adverse Cardiac and Cerebrovascular Events (MACCE)

Description

the occurrence of MACCE at 2 years' clinical follow-up, including all-cause death, myocardial infarction, stroke, and repeated revascularization

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Bleeding events

Description

individual component of MACCE

Time Frame

2 years

Title

Hospital duration (day)

Time Frame

up yo 2 years

Title

Rate of complete revascularization at index hospitalization

Description

rate of complete revascularization at index hospitalization (defined by Quantitative flow ration[QFR] or Fraction flow reserve[FFR])

Time Frame

2 years

Title

Stent thrombosis event

Description

stent thrombosis defined by Academic Research Consortium (ARC)

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 Years and older signed the informed consent indicated for revascularization, with possible bypass segment in LAD and amendable lesions by PCI in other vessels anatomy requiring as following: (1) Multivessel CAD involving the LAD (proximal or mid) and/or LM (ostial, mid-shaft or distal) with at least 1 other epicardial coronary artery requiring treatment in LCX or RCA, including: (2) LAD disease, and a major diagonal lesion, either bifurcation or independent in location, with both requiring revascularization (determined by QFR or FFR) (3) LM distal bifurcation lesion (Medina 1,1,1), intended for 2-stent approach if randomized to PCI Heart team discussion after angiogram, with conclusion of suitable candidate for either PCI or HCR Able to tolerate and no plans to interrupt dual anti-platelet therapy for 3~12 months Willing to comply with 2-year clinical follow-up Exclusion Criteria: Previous cardiac or thoracic surgery Previous PCI of the LM and/or LAD within 12 months Totally occluded left main vessel Cardiogenic shock or LVEF <30% Previous STEMI within 30-day prior to randomization Concomitant vascular or other cardiac disease with plan of surgical treatment Indication for chronic oral anticoagulation therapy Previous stroke history within 6-month prior to randomization Survival expectation less than 3 years due to non-cardiac illness Allergy or hypersensitivity to any of the study drugs or devices used in the trial Enrolled in additional clinical study Informed consent not available or noncompliance with follow-up Pregnant

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qi Zhang, MD, PhD

Phone

+86-21-38804518

zhangqnh@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qi Zhang, MD, PhD

Organizational Affiliation

Shanghai East Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Shanghai East Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200120

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qi Zhang, MD, PhD

Phone

+86-21-38804518

zhangqnh@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of One-Stage Hybrid Coronary Revascularization

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