NCT01875835

Brief Summary

Primary percutaneous coronary intervention (PCI) represents the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI), since it is more effective than thrombolytic regimens in reducing adverse events, including death. Drug-eluting stents (DES) are currently being widely used in patients with STEMI. The effectiveness of DES to reduce restenosis and the need for revascularization compared with bare-metal stents (BMS) has been documented in randomized controlled trials. The first-generation DESs implanted in STEMI have been associated with delayed healing and incomplete strut coverage. Therefore, in patients with implanted DES, longer duration of dual antiplatelet therapy is needed. The second-generation DESs (ZES and EES) have been improved the drug and polymer, which have been proved to improve neointima healing compared with the first generation DESs. However, the difference of strut coverage between EES and BMS implanted in STEMI patients is unknown. In this study, we assess the neointimal coverage at 3-month and 12-month follow-up in EES and BMS implanted in patients with STEMI by optical coherence tomography.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

June 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

2.7 years

First QC Date

June 5, 2013

Last Update Submit

November 27, 2024

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardiac infarctionBare-metal stentEverolimus-eluting stentOptical coherence tomography

Outcome Measures

Primary Outcomes (1)

  • Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by frequency domain optical coherence tomography (FD-OCT).

    The covered strut is defined as the strut has definite neointimal over it. And the rate of covered struts was calculated as the number of covered struts divided the number of total struts.

    3-month

Secondary Outcomes (4)

  • Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by FD-OCT.

    12-month

  • Comparison of the rate of malaposed struts to EES vs BMS implanted in STEMI patients by FD-OCT.

    3-month

  • Comparison of the rate of malaposed struts to the EES vs BMS implanted in STEMI patients by FD-OCT.

    12-month

  • Major adverse cardiovascular events (MACE)

    12-month

Study Arms (2)

DES

ACTIVE COMPARATOR

Everolimus-Eluting Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI)

Device: Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)

BMS

ACTIVE COMPARATOR

Bare-Metal Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI)

Device: Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)

Interventions

Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)DEVICE
DES
Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)DEVICE
BMS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-75 years
  • Acute MI with ST-segment elevation, within 12 hours from symptoms onset.
  • Length of culprit lesion≤25mm.
  • Vessel size in between 2.5 and 4.0 mm.
  • Signed patient informed consent.

You may not qualify if:

  • Prior administration of thrombolytic therapy.
  • Cardiogenic shock.
  • Renal failure (Crea≥2.0mg/dL).
  • Recent major bleeding.
  • Allergy to heparin, aspirin, clopidogrel, everolimus, the polymer components of the Xience V stent, stainless steel, or contrast media.
  • Left main disease
  • Multi-vessel lesion
  • Other hemodynamically significant lesion(s) is present in the infarct vessel (or side branches)
  • Angiography demonstrates the infarct lesion to be at the site of a previously implanted stent or in bypass grafts.
  • No suitable anatomy for OCT scan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

Location

Study Officials

  • Bo Yu, MD,PhD

    The Second Affiliated Hospital of Harbin Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The second affiliated hospitai of Harbin medical university

Study Record Dates

First Submitted

June 5, 2013

First Posted

June 12, 2013

Study Start

June 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

December 2, 2024

Record last verified: 2024-11

Locations

CN(1)