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

NCT03491891 | Completed Results DMC

• 1 other identifier: wx19871203
• Study Type: observational
• Target: 8,476
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stent Thrombosis

Keywords

Very Late Stent Thrombosis; New generation DES

Outcome Measures

Primary Outcomes (1)

• Very Late Stent Thrombosis

  very late stent thrombosis demonstrated by coronary angiography

  Five years

Study Arms (2)

derivation cohort

no interventions will be administrated

validation cohort

no interventions will be administrated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead
• First Affiliated Hospital of Shantou University Medical College: collaborator

Study Sites (1)

Jilin University 1st Hospital

Changchun, Jilin, 130021, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples including serum and plasma

Results Point of Contact

• Title: Xiang Wang
• Organization: First Hospital of Jilin University

jdwxiang123@126.com

+86-13504321434

Study Officials

• yang zheng

  Jilin University 1st Hospital Cardiovascular Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 9, 2018
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2019
• Last Updated: September 20, 2019
• Results First Posted: September 20, 2019

Record last verified: 2018-06

Locations

CN (1)