A Prospective, Multi-center,Randomized Controled Trial of POST-dilatation to Improve Outcomes in Acute STEMI Patients Undergoing Primary PCI After Thrombus Aspiration and DES Implantation With OCT Assessment

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country40 target enrollmentApril 2014

ConditionsAcute Myocardial Infarction

Overview

Phase: N/A
Intervention: Not specified
Conditions: Acute Myocardial Infarction
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment: 40
Locations: 1
Primary Endpoint: Rate of Incomplete Stent Apposition (ISA) in OCT at 7 month
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the effective and safety of post-dilatation in patients with acute ST segment elevated myocardial infarction undergoing primary percutaneous intervention after thrombus aspiration assessed by optical coherence tomography to examine stent Incomplete apposition and strut coverage in patients treated with drug-eluting stents .

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

July 2015

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Responsible Party

Principal Investigator

Jian'an Wang,MD,PhD

Professor, Chief of Heart Center, and President of the Hospital

Second Affiliated Hospital, School of Medicine, Zhejiang University

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years
•STEMI \>20 mins and \<12 hours in duration
•ST-segment elevation of ≥1 mm in ≥2 contiguous leads; or Presumably new left bundle branch block; or True posterior MI with ST depression of ≥1 mm in ≥2 contiguous anterior leads
•Written, informed consent
•Angiographic Inclusion Criteria
•The presence of least 1 acute infarct artery target vessel\* in which:
•ALL significant lesions are eligible for stenting with study stents, and
•ALL such lesions have a visually estimated reference diameter ≥2.5 mm and ≤4.0 mm
•All culprit lesion TIMI Flow ≤ 0 or 1 Grade prior to guide wire crossing
•Expected ability to deliver the stent(s) to all culprit lesions (absence of excessive proximal tortuosity or severe calcification)

Exclusion Criteria

•Contraindication to any of the study medications
•Patients with cardiogenic shock
•History of bleeding diathesis or known coagulopathy , or will refuse blood transfusions
•History of intracerebral mass, aneurysm, AVM, or hemorrhagic stroke; stroke or TIA within 6 months or any permanent neurologic deficit; GI or GU bleed within 2 months, or major surgery within 6 weeks; recent or known platelet count \<100,000 cells/mm3 or hgb \<10 g/dL
•Planned elective surgical procedure that would necessitate interruption of thienopyridines during the first 6 months post enrollment
•Angiographic Exclusion Criteria
•Bifurcation lesion definitely requiring implantation of stents in both the main vessel + side branch
•Infarct related artery is an unprotected left main
•\>38 mm of study stent length anticipated
•Infarction due to stent thrombosis, or infarct lesion at the site of a previously implanted stent

Outcomes

Primary Outcomes

Rate of Incomplete Stent Apposition (ISA) in OCT at 7 month

Time Frame: 7 months after primary PCI

Secondary Outcomes

Final TIMI flow grade 3(Immediately after primary PCI procedure (up to 2 min))
Final TIMI blush Grade 3(Immediately after primary PCI procedure (up to 2 min))
In-stent and in-segment late loss(7 months after primary PCI)
Rate of strut coverage in OCT at 7 month(7 months after primary PCI)
Stent thrombus rate at 30 day,7 month and 12 month(30 days, 7 months and 12 months after primary PCI)
Rate of ST resolution 70% at 30 day(30 days after primary PCI)
TLR ,TLF at 7 month and 12 month(7 months and 12months after primary PCI)
MACE at 7 month and 12 month(7 months and 12 months after primary PCI)