Status:
UNKNOWN
Efficacy and Safety of One-Stage Hybrid Coronary Revascularization
Lead Sponsor:
Shanghai East Hospital
Conditions:
Multivessel Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04811586
Start Date
December 30 2020
End Date
December 1 2023
Last Update
March 23 2021
Active Locations (1)
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1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120