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

Stent Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03491891
• Other study ID #: wx19871203
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: June 1, 2019

Study information

• Verified date: June 2018
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8476
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stent Thrombosis
• Thrombosis

Locations

Country	Name	City	State
China	Jilin University 1st Hospital	Changchun	Jilin

Sponsors (2)

Lead Sponsor	Collaborator
First Hospital of Jilin University	First Affiliated Hospital of Shantou University Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Very Late Stent Thrombosis	very late stent thrombosis demonstrated by coronary angiography	Five years