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POST-dilatation to Improve Outcomes in Acute STEMI Patients Undergoing Primary With OCT Assessment

NCT02121223 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-04-23

No results posted yet for this study

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 .

Conditions

  • Acute Myocardial Infarction

Interventions

DEVICE

post-dilatation with a Quantum Maverick balloon

post-dilatation with a Quantum Maverick balloon at high pressure (\>=16atm) for at least 15 seconds.

DEVICE

manual thrombus aspiration + Promus Element stent implant

manual thrombus aspiration followed by Promus Element stent implantation at normal pressure

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • Shanghai East Hospital

    collaborator OTHER

  • Ningbo No. 1 Hospital

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Jianan Wang, MD · Second Affiliated Hospital Zhejiang University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-05-31
Completion
2015-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02121223 on ClinicalTrials.gov