Multivessel Coronary Artery Disease Clinical Trial
— HCR-EASTOfficial 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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. 18 Years and older 2. signed the informed consent 3. indicated for revascularization, with possible bypass segment in LAD and amendable lesions by PCI in other vessels 4. 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 5. Heart team discussion after angiogram, with conclusion of suitable candidate for either PCI or HCR 6. Able to tolerate and no plans to interrupt dual anti-platelet therapy for 3~12 months 7. Willing to comply with 2-year clinical follow-up Exclusion Criteria: 1. Previous cardiac or thoracic surgery 2. Previous PCI of the LM and/or LAD within 12 months 3. Totally occluded left main vessel 4. Cardiogenic shock or LVEF <30% 5. Previous STEMI within 30-day prior to randomization 6. Concomitant vascular or other cardiac disease with plan of surgical treatment 7. Indication for chronic oral anticoagulation therapy 8. Previous stroke history within 6-month prior to randomization 9. Survival expectation less than 3 years due to non-cardiac illness 10. Allergy or hypersensitivity to any of the study drugs or devices used in the trial 11. Enrolled in additional clinical study 12. Informed consent not available or noncompliance with follow-up 13. Pregnant |
Country | Name | City | State |
---|---|---|---|
China | Shanghai East Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai East Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 2 years | |
Secondary | Bleeding events | individual component of MACCE | 2 years | |
Secondary | Hospital duration (day) | up yo 2 years | ||
Secondary | 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]) | 2 years | |
Secondary | Stent thrombosis event | stent thrombosis defined by Academic Research Consortium (ARC) | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05669222 -
The FAVOR V AMI Trial
|
N/A | |
Not yet recruiting |
NCT06025071 -
Residual Inflammatory Risk-Guided colcHicine in Elderly Trial
|
Phase 4 | |
Recruiting |
NCT05786131 -
Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI
|
N/A | |
Recruiting |
NCT06168305 -
Safety and Effectiveness of GENOSS DES in Patients With Multivessel Coronary Artery Disease
|
||
Not yet recruiting |
NCT05835167 -
Complete Revascularization Via Inferior Part-sternotomy
|
N/A | |
Completed |
NCT01881555 -
Functional Testing Underlying Coronary Revascularisation
|
N/A | |
Not yet recruiting |
NCT06400290 -
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
|
N/A | |
Active, not recruiting |
NCT01621438 -
Clinical Implication of 3-vessel Fractional Flow Reserve (FFR)
|
N/A | |
Not yet recruiting |
NCT06378775 -
Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery
|
N/A | |
Completed |
NCT05125367 -
Ten-Year Outcomes of Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease
|
||
Completed |
NCT01947439 -
Comparison of the Biolimus A9-eluting Stent With the Zotarolimus -Eluting Stent in Multi-vessel PCI
|
N/A | |
Recruiting |
NCT05333068 -
COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events
|
N/A | |
Withdrawn |
NCT03851276 -
A Multicentre, Pilot Study to Evaluate the Safety and the Feasibility of Planning and Execution of Surgical Revascularization in Patients With Complex Coronary Artery Disease, Based Solely on MSCT Imaging Utilizing GE Healthcare Revolution CT and HeartFlow FFRCT.
|
Phase 4 | |
Completed |
NCT02813473 -
SYNTAX III REVOLUTION Trial: A Randomized Study Investigating the Use of CT Scan and Angiography of the Heart to Help the Doctors Decide Which Method is the Best to Improve Blood Supply to the Heart in Patients With Complex Coronary Artery Disease
|
||
Recruiting |
NCT05698719 -
Validation of vFFR as Compared to FFR to Guide Revascularization of Non-culprit Lesions in STEMI Patients
|
||
Completed |
NCT01399736 -
Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD.
|
N/A | |
Not yet recruiting |
NCT01311323 -
Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease
|
N/A | |
Completed |
NCT00818792 -
Randomized Comparison of xiEnce and visioN Coronary Stents in the sAme muLtivessel Patient With Chronic kiDnEy diSease
|
Phase 2 | |
Completed |
NCT01199419 -
Cost-effectiveness of PCI With Taxus vs CABG - 5 Years FUP
|
N/A | |
Completed |
NCT04743154 -
In-hospital Versus After-discharge Complete Revascularization
|
N/A |