Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice (IRIS-DES)

June 10, 2025 updated by: Seung-Jung Park

Evaluation of Effectiveness and Safety of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice

The objective of this study is to evaluate effectiveness and safety of the new drug-eluting stent (DES), as compared with the first-,second-,third-, and fourth-generation DES, in the "real world" daily practice.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Consecutive patients receiving New DES without a mixture of other DES

Study Type

Observational

Enrollment (Estimated)

50000

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

consecutive patients amenable to PCI

Description

Inclusion Criteria:

  • coronary disease amenable to percutaneous coronary intervention (PCI)
  • no clinical and lesion limitations

Exclusion Criteria:

  • patients with a mixture of several DES
  • terminal illness with life expectancy less than 1 year
  • patients with cardiogenic shock

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
DESSIAN
consecutive patients receiving CYPHER stent
K-XIENCE
consecutive patients receiving Xience stent
GENOUS
consecutive patients receiving GENOUS stent
ELEMENT
consecutive patients receiving PROMUS-ELEMENT stent
PRIME
consecutive patients receiving XIENCE-PRIME stent
NOBORI
consecutive patients receiving NOBORI stent
INTEGRITY
consecutive patients receiving RESOLUTE-INTEGRITY stent
XPEDITION
consecutive patients receiving XIENCE-XPEDITION stent
BIOMATRIX
consecutive patients receiving BIOMATRIX stent
CILOTAX
consecutive patients receiving CILOTAX stent
DEB
consecutive patients receiving Drug eluting balloon
DESYNE
consecutive patients receiving DESYNE stent
PREMIER
consecutive patients receiving PROMUS-PREMIER stent
ORSIRO
consecutive patients receiving ORSIRO stent
ONYX
consecutive patients receiving ONYX stent
BVS
consecutive patients receiving Bioresorbable Vascular Scaffold
BVS AMI
consecutive acute myocardial infarction patients receiving Bioresorbable Vascular Scaffold
Ultimaster
consecutive patients receiving Ultimaster stent
Synergy
consecutive patients receiving Synergy stent
Biofreedom
consecutive patients receiving Biofreedom stent
Firehawk
consecutive patients receiving Firehawk stent
DESyne X2
consecutive patients receiving DESyne X2 stent
Sierra
consecutive patients receiving Sierra stent
Tansei
consecutive patients receiving Tansei stent
Synergy XD and Synergy Megatron™
consecutive patients receiving Synergy XD or Synergy Megatron™ stent
Xience-Skypoint
consecutive patients receiving Xience-Skypoint stent
Coroflex ISAR NEO
consecutive patients receiving Coroflex ISAR NEO stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
Time Frame: at 12 months post procedure
at 12 months post procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedural success
Time Frame: at 1 day
at 1 day
Death (all-cause and cardiac)
Time Frame: at 12 months and annually up to 5 years
at 12 months and annually up to 5 years
Myocardial infarction
Time Frame: at 12 months and annually up to 5 years
at 12 months and annually up to 5 years
Stent thrombosis
Time Frame: at 12 months and annually up to 5 years
at 12 months and annually up to 5 years
Target-lesion and target-vessel revascularization
Time Frame: at 12 months and annually up to 5 years
at 12 months and annually up to 5 years
Stroke
Time Frame: at 12 months and annually up to 5 years
at 12 months and annually up to 5 years

Collaborators and Investigators

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

Sponsor

Seung-Jung Park

Collaborators

CardioVascular Research Foundation, Korea

Investigators

  • Study Chair: Seung-jung Park, MD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2009

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

August 19, 2010

First Submitted That Met QC Criteria

August 20, 2010

First Posted (Estimated)

August 23, 2010

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 10, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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