NCT03282773

Brief Summary

This study will compare clinical outcomes of immediate stent implantation with deferred stent implantation(4-10days after primary angiography) for patients presented with acute myocardial infarction due to left main coronary artery occlusion.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

4.2 years

First QC Date

September 10, 2017

Last Update Submit

November 18, 2017

Conditions

Acute Myocardial InfarctionPercutaneous Coronary Intervention

Keywords

acute myocardial infarctionpercutaneous coronary interventiondeferred stent implantation

Outcome Measures

Primary Outcomes (1)

  • Composite of cardiac death and recurrent myocardial infarction

    Recorded in follow-up

    30 days after primary angiography

Secondary Outcomes (3)

  • All cause death, cardiac death, recurrent myocardial infarction, target vessel revascularization

    30 days after primary angiography

  • Residual stenosis of left main coronary artery

    Immediately after stent implantation and 12 months after primary angiography

  • Left ventricular ejection fraction

    30 days and 12 months after primary angiography

Study Arms (2)

Deferred stent implantation

EXPERIMENTAL

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

Device: Deferred stent implantation

Immediate stent implantation

ACTIVE COMPARATOR

Drug-eluting stents are implanted immediately after primary angiography and restoration of blood flow in left main coroanry artery

Device: Immediate stent implantation

Interventions

Deferred stent implantationDEVICE

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.

Deferred stent implantation
Immediate stent implantationDEVICE

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.

Immediate stent implantation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of acute myocardial infarction occured within 12 hours
  • 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

You may not qualify if:

  • Life expectancy less than 1 years
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30850023DERIVED

Study Officials

  • Junbo Ge, M.D.

    Zhongshan Hospital,Shanghai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Zhang, M.D.

CONTACT

13917149007zhang.feng@zs-hospital.sh.cn

Yang Gao, M.D.

CONTACT

18801970322gysc20@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2017

First Posted

September 14, 2017

Study Start

November 1, 2017

Primary Completion

December 31, 2021

Study Completion

July 31, 2022

Last Updated

November 21, 2017

Record last verified: 2017-11

Locations

CN(1)