Optimal Strategy of Primary PCI for Left Main Coronary Artery Occlusion Induced AMI
NCT ID: NCT03282773
Last Updated: 2017-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
480 participants
INTERVENTIONAL
2017-11-01
2022-07-31
Brief Summary
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Detailed Description
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This prospective, multicenter, randomized trial is aimed to compare immediate stenting with deferred stenting for LM-AMI with 30 centers in China involved. We hope to determine whether deferred stenting is superior to conventional strategy for primary PCI of AMI caused by left main coronary artery occlusion in improving long-term clinical outcomes and cardiac function.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Deferred stent implantation
Drug-eluting stents are implanted 4-10 days after primary angiography and restoration of blood flow in left main coroanry artery in a secondary PCI
Deferred stent implantation
Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted 4-10 days after restoration of blood flow in left main coronary artery in a secondary PCI.
Immediate stent implantation
Drug-eluting stents are implanted immediately after primary angiography and restoration of blood flow in left main coroanry artery
Immediate stent implantation
Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted immediately after restoration of blood flow in left main coronary artery in a secondary PCI.
Interventions
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Deferred stent implantation
Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted 4-10 days after restoration of blood flow in left main coronary artery in a secondary PCI.
Immediate stent implantation
Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted immediately after restoration of blood flow in left main coronary artery in a secondary PCI.
Eligibility Criteria
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Inclusion Criteria
* Left main coronary artery occlusion confirmed by angiography
* Left main coronary artery occlusion (TIMI flow 0,1 or 2) confirmed by primary angiography, TIMI flow grade 3 achieved after pretreatment of thrombus aspiration or balloon dilatation
Exclusion Criteria
* Cardiogenic shock
* Chronic kidney disease, stage 4 by KDOQI(GFR\<30ml/min)
* Contraindications to aspirin or other anti-platelet drugs
* Allergy to contrast agent, rapamycin or paclitaxel
* Patients who are included in other ongoing trials
* Pregnant female
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Junbo Ge, M.D.
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Hospital,Shanghai
Locations
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Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Feng Zhang, M.D.
Role: primary
Yang Gao, M.D.
Role: backup
References
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Gao Y, Zhang F, Li C, Dai Y, Yang J, Qu Y, Qian J, Ge J; OPTIMAL trial investigators. Optimal strategy of primary percutaneous coronary intervention for acute myocardial infarction due to unprotected left main coronary artery occlusion (OPTIMAL): study protocol for a randomised controlled trial. Trials. 2019 Mar 8;20(1):162. doi: 10.1186/s13063-019-3211-0.
Other Identifiers
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B2017-104
Identifier Type: -
Identifier Source: org_study_id