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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by CardioVascular Research Foundation, Korea
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01186133
First received: August 19, 2010
Last updated: June 16, 2016
Last verified: June 2016
  Purpose
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.

Condition
Coronary Artery Disease
Percutaneous Transluminal Coronary Angioplasty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Effectiveness and Safety of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice

Resource links provided by NLM:


Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) [ Time Frame: at 12 months post procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • death (all-cause and cardiac) [ Time Frame: at 12 months and annually up to 5 years ] [ Designated as safety issue: Yes ]
  • myocardial infarction [ Time Frame: at 12 months and annually up to 5 years ] [ Designated as safety issue: Yes ]
  • stent thrombosis [ Time Frame: at 12 months and annually up to 5 years ] [ Designated as safety issue: Yes ]
  • target-lesion and target-vessel revascularization [ Time Frame: at 12 months and annually up to 5 years ] [ Designated as safety issue: Yes ]
  • procedural success [ Time Frame: at 1 day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25000
Study Start Date: January 2009
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:
Consecutive patients receiving New DES without a mixture of other DES
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
consecutive patients amenable to PCI
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186133

Contacts
Contact: Seung-Jung Park, MD sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD dwpark@amc.seoul.kr

Locations
Korea, Republic of
Korean centres Recruiting
Various, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Study Chair: Seung-Jung Park, MD Asan Medical Center
  More Information

Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01186133     History of Changes
Other Study ID Numbers: 2010-035 
Study First Received: August 19, 2010
Last Updated: June 16, 2016
Health Authority: Korea: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No
Plan Description: This is not a publicly funded trial.

Keywords provided by CardioVascular Research Foundation, Korea:
coronary disease
drug eluting stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 23, 2016