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

Primary Purpose

Acute Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
post-dilatation with a Quantum Maverick balloon
manual thrombus aspiration + Promus Element stent implant
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring acute ST segment elevated myocardial infarction, primary percutaneous intervention, Stent Incomplete Apposition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Second Affiliated Hospital Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Post-dilatation

Arm Description

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

Patients in this group will receive high pressure post-dilatation with a Quantum Maverick balloon after manual thrombus aspiration + Promus Element stent implantation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Final TIMI flow grade 3
Final TIMI blush Grade 3
Rate of ST resolution 70% at 30 day
Rate of strut coverage in OCT at 7 month
MACE at 7 month and 12 month
TLR ,TLF at 7 month and 12 month
Stent thrombus rate at 30 day,7 month and 12 month
In-stent and in-segment late loss

Full Information

First Posted
April 3, 2014
Last Updated
April 22, 2014
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
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1. Study Identification

Unique Protocol Identification Number
NCT02121223
Brief Title
POST-dilatation to Improve Outcomes in Acute STEMI Patients Undergoing Primary With OCT Assessment
Acronym
POST-STEMI
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
acute ST segment elevated myocardial infarction, primary percutaneous intervention, Stent Incomplete Apposition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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
Arm Title
Post-dilatation
Arm Type
Experimental
Arm Description
Patients in this group will receive high pressure post-dilatation with a Quantum Maverick balloon after manual thrombus aspiration + Promus Element stent implantation
Intervention Type
Device
Intervention Name(s)
post-dilatation with a Quantum Maverick balloon
Intervention Description
post-dilatation with a Quantum Maverick balloon at high pressure (>=16atm) for at least 15 seconds.
Intervention Type
Device
Intervention Name(s)
manual thrombus aspiration + Promus Element stent implant
Intervention Description
manual thrombus aspiration followed by Promus Element stent implantation at normal pressure
Primary Outcome Measure Information:
Title
Rate of Incomplete Stent Apposition (ISA) in OCT at 7 month
Time Frame
7 months after primary PCI
Secondary Outcome Measure Information:
Title
Final TIMI flow grade 3
Time Frame
Immediately after primary PCI procedure (up to 2 min)
Title
Final TIMI blush Grade 3
Time Frame
Immediately after primary PCI procedure (up to 2 min)
Title
Rate of ST resolution 70% at 30 day
Time Frame
30 days after primary PCI
Title
Rate of strut coverage in OCT at 7 month
Time Frame
7 months after primary PCI
Title
MACE at 7 month and 12 month
Time Frame
7 months and 12 months after primary PCI
Title
TLR ,TLF at 7 month and 12 month
Time Frame
7 months and 12months after primary PCI
Title
Stent thrombus rate at 30 day,7 month and 12 month
Time Frame
30 days, 7 months and 12 months after primary PCI
Title
In-stent and in-segment late loss
Time Frame
7 months after primary PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Jiang, MD
Phone
8657187784705
Email
drjayj@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianan Wang, MD
Organizational Affiliation
Second Affiliated Hospital Zhejiang University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Jiang, MD
Phone
8657187784705
Email
drjayj@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32076473
Citation
Jiang J, Tian NL, Cui HB, Li CL, Liu XB, Dong L, Sun Y, Chen XM, Chen SL, Xu B, Wang JA. Post-dilatation improves stent apposition in patients with ST-segment elevation myocardial infarction receiving primary percutaneous intervention: A multicenter, randomized controlled trial using optical coherence tomography. World J Emerg Med. 2020;11(2):87-92. doi: 10.5847/wjem.j.1920-8642.2020.02.004.
Results Reference
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POST-dilatation to Improve Outcomes in Acute STEMI Patients Undergoing Primary With OCT Assessment

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