Factors Contribute to Very Late Stent Thrombosis After New Generation DES Implantation in China

August 19, 2019 updated by: The First Hospital of Jilin University

Correlates and Mehcanisms Underlying Very Late Stent Thrombosis After Implantation of New Generation DES in China

The investigators sought to identify and verify the potential correlates and mechanisms of Very Late Stent Thrombosis (VLST) after the implantation of new generation drug eluting steng in China from an analysis of multicenter registries.

Study Overview

Status

Completed

Conditions

Detailed Description

This study represents a patient-level pooled analysis of patients undergoing percutaneous coronary intervention with stent implantation for acute coronary syndrome. Multiple aspects including clinical, angiographic, procedural characteristics , intravascular imaging results and blood samples were collected at index PCI and the time of VLST or CAG during follow-up, in order to reveal the potential mechanisms or risk factors that contribute to the development of VLST.

Study Type

Observational

Enrollment (Actual)

8476

Contacts and Locations

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

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130021
        • Jilin University 1st Hospital

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

Sampling Method

Non-Probability Sample

Study Population

Patients>18y,admitted for acute coronary syndrome,successfully underwent PCI with at least one stent, sign informed consent were included.Patients' expected lifetime was less than 1 year for any severe disease(such as tumor,severe respiratory failure et al),and with a surgical plan for important organs within 1 year after surgery and anti-platelet drugs should be discontinued, refusing to sign informed consent, died prior to discharge, unable to participate in regular follow-up were excluded.

Description

Inclusion Criteria:

  • Patients>18y,admitted for acute coronary syndrome,successfully underwent PCI with at least one stent, sign informed consent.

Exclusion Criteria:

  • Expected lifetime was less than 1 year for any severe disease(such as tumor,severe respiratory failure et al). There is a surgical plan for important organs within 1 year after surgery and anti-platelet drugs should be discontinued. Refusing to sign informed consent.Died prior to discharge. Poor compliance, unable to participate in regular follow-up.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
derivation cohort
no interventions will be administrated
validation cohort
no interventions will be administrated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Very Late Stent Thrombosis
Time Frame: Five years
very late stent thrombosis demonstrated by coronary angiography
Five years

Collaborators and Investigators

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

Sponsor

The First Hospital of Jilin University

Collaborators

First Affiliated Hospital of Shantou University Medical College

Investigators

  • Study Director: yang zheng, Jilin University 1st Hospital Cardiovascular Center

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 (Actual)

January 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

April 2, 2018

First Submitted That Met QC Criteria

April 2, 2018

First Posted (Actual)

April 9, 2018

Study Record Updates

Last Update Posted (Actual)

September 20, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • wx19871203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

When the investigation is completed,we will share it with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Stent Thrombosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe