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

April 22, 2014 updated by: Jian'an Wang,MD,PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Second Affiliated Hospital ZheJiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Clinical 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:

    1. ALL significant lesions are eligible for stenting with study stents, and
    2. ALL such lesions have a visually estimated reference diameter ≥2.5 mm and ≤4.0 mm
    3. 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)
  • Expected ability to fully expand the stent(s) at all culprit lesions (absence of marked calcification)

Clinical 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
  • High likelihood of CABG within 30 days anticipated
  • The culprit lesion will be judged unsuitable for OCT procedure, because of conditions such as left main trunk disease or shock vital

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Patients in control group will receive current standard therapy for STEMI: manual thrombus aspiration + Promus Element stent implantation ( with a pressure less than 12 atm), but not post-dilatation
Device: manual thrombus aspiration + Promus Element stent implant
manual thrombus aspiration followed by Promus Element stent implantation at normal pressure
Experimental: Post-dilatation
Patients in this group will receive high pressure post-dilatation with a Quantum Maverick balloon after manual thrombus aspiration + Promus Element stent implantation
Device: manual thrombus aspiration + Promus Element stent implant
manual thrombus aspiration followed by Promus Element stent implantation at normal pressure
Device: post-dilatation with a Quantum Maverick balloon
post-dilatation with a Quantum Maverick balloon at high pressure (>=16atm) for at least 15 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of Incomplete Stent Apposition (ISA) in OCT at 7 month
Time Frame: 7 months after primary PCI
7 months after primary PCI

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

The First Affiliated Hospital with Nanjing Medical University
Shanghai East Hospital
Ningbo No. 1 Hospital

Investigators

  • Principal Investigator: Jianan Wang, MD, Second Affiliated Hospital ZheJiang University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

April 3, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Estimate)

April 23, 2014

Last Update Submitted That Met QC Criteria

April 22, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHZJU CT002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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