FindTrial
Sign In

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03491891
Enrollment
8476
Registered
2018-04-09
Start date
2014-01-01
Completion date
2019-06-01
Last updated
2019-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stent Thrombosis

Keywords

Very Late Stent Thrombosis, New generation DES

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.

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.

Interventions

None listed

Sponsors

First Affiliated Hospital of Shantou University Medical College
CollaboratorOTHER
The First Hospital of Jilin University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Very Late Stent ThrombosisFive yearsvery late stent thrombosis demonstrated by coronary angiography

Countries

China

Participant flow

Participants by arm

ArmCount
Derivation Cohort
Patients enrolled in Jilin University First Hospital, no interventions will be administrated
5,185
Validation Cohort
Patients enrolled in First Affiliated Hosptal of Shantou University, no interventions will be administrated
2,058
Total7,243

Baseline characteristics

CharacteristicDerivation CohortValidation CohortTotal
Age, Continuous59.846 years
STANDARD_DEVIATION 9.95
60.00 years
STANDARD_DEVIATION 10.22
59.96 years
STANDARD_DEVIATION 10.18
AMI as admitting diagnosis3160 Participants1258 Participants4418 Participants
Cardiogenic shock113 Participants17 Participants130 Participants
Current smoker2914 Participants1202 Participants4116 Participants
Dyslipidaemia1640 Participants515 Participants2155 Participants
History of drinking764 Participants327 Participants1091 Participants
History of heart failure137 Participants58 Participants195 Participants
History of PVD88 Participants42 Participants130 Participants
History of stroke/TIA379 Participants170 Participants549 Participants
History or Diabetes Mellitus1329 participants550 participants1879 participants
Hypertension2721 Participants1073 Participants3794 Participants
Previous CABG144 Participants65 Participants209 Participants
Previous MI357 Participants114 Participants471 Participants
Previous PCI104 Participants46 Participants150 Participants
Race and Ethnicity Not Collected——0 Participants
Sex: Female, Male
Female
1628 Participants644 Participants2272 Participants
Sex: Female, Male
Male
3557 Participants1414 Participants4971 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
316 / 6,038132 / 2,438
other
Total, other adverse events
0 / 6,0380 / 2,438
serious
Total, serious adverse events
0 / 6,0380 / 2,438

Outcome results

Primary

Very Late Stent Thrombosis

very late stent thrombosis demonstrated by coronary angiography

Time frame: Five years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Derivation CohortVery Late Stent Thrombosis92 Participants
Validation CohortVery Late Stent Thrombosis35 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026