Multivessel Coronary Artery DiseaseHCR-EASTNCT04811586
Efficacy and Safety of One-Stage Hybrid Coronary Revascularization
A study testing coronary revascularization in people with Multivessel Coronary Artery Disease, run by Shanghai East Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multivessel Coronary Artery Disease
- What is being tested?
- coronary revascularization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2020to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Qi Zhang, MD, PhD, +86-21-38804518, zhangqnh@hotmail.com
About this study
Official title: Efficacy and Safety of One-Step Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention for Patients With Multivessel Disease
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.
- Conditions
- Multivessel Coronary Artery Disease
- Being tested
- coronary revascularization
- Keywords
- hybrid coronary revascularization (HCR), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), multivessel coronary artery disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary revascularizationProcedure or surgery
to improve the blood supply for coronary arteries by using either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
| Study group | Role | What they receive |
|---|---|---|
| one-step Hybrid Coronary Revascularization (HCR) | Experimental | 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. Receives: Procedure: coronary revascularization |
| Percutaneous Coronary Intervention (PCI) | Active comparator | PCI will be performed using standard technique at the discretion of interventional cardiologist with DES implantation in a routine catheter lab. Receives: Procedure: coronary revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (4)
Bleeding events
individual component of MACCE
Measured: 2 years
Hospital duration (day)
Measured: up yo 2 years
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])
Measured: 2 years
Stent thrombosis event
stent thrombosis defined by Academic Research Consortium (ARC)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start30 Dec 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multivessel Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qi Zhang, MD, PhD, Study director, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811586
- Sponsor's protocol ID
- HCR-EAST
- Acronym
- HCR-EAST
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of One-Step Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention for Patients With Multivessel Disease
- ClinicalTrials.gov ID
- NCT04811586
- Acronym / sponsor ID
- HCR-EAST / HCR-EAST
- Conditions
- Multivessel Coronary Artery Disease
- Keywords
- hybrid coronary revascularization (HCR), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), multivessel coronary artery disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one-step Hybrid Coronary Revascularization (HCR) | Experimental | Procedure: coronary revascularizationOne-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. |
| Percutaneous Coronary Intervention (PCI) | Active comparator | Procedure: coronary revascularizationPCI will be performed using standard technique at the discretion of interventional cardiologist with DES implantation in a routine catheter lab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary revascularizationto improve the blood supply for coronary arteries by using either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) | Procedure or surgery | Percutaneous Coronary Intervention (PCI), one-step Hybrid Coronary Revascularization (HCR) |
Primary outcome
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time frame: 2 years
the occurrence of MACCE at 2 years' clinical follow-up, including all-cause death, myocardial infarction, stroke, and repeated revascularization
4 secondary outcomes
Bleeding events
Time frame: 2 years
Hospital duration (day)
Time frame: up yo 2 years
Rate of complete revascularization at index hospitalization
Time frame: 2 years
Stent thrombosis event
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qi Zhang, MD, PhD study director
Shanghai East Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coronary revascularization in people with Multivessel Coronary Artery Disease, run by Shanghai East Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qi Zhang, MD, PhD (+86-21-38804518, zhangqnh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac and Cerebrovascular Events (MACCE) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.