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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 November 2012 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: November 22, 2012
Last verified: November 2012
  Purpose

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


Condition
Coronary Artery Disease

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

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 ] [ Designated as safety issue: Yes ]
  • myocardial infarction [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • stent thrombosis [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • target-lesion and target-vessel revascularization [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • procedural success [ Time Frame: at 1 day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18600
Study Start Date: January 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cypher stent group (DESSIAN registry)
consecutive patients receiving cypher stent
Xience stent group (K-Xience registry)
consecutive patients receiving Xience stent
Nobori stent group
consecutive patients receiving Nobori stent
PROMUS ELEMENT group
consecutive patients receiving Promus element stent
Biomatrix stent group
consecutive patients receiving Biomatrix stent
Genous stent group
STEMI patients receiving Genous stent
IRIS-PRIME group
consecutive patients receiving XIENCE-PRIME stent
IRIS-RESOLUTE group
consecutive patients receiving Resolute-Integrity stent
IRIS-CILOTAX group
consecutive patients receiving cilotax stent

Detailed Description:

evaluate effectiveness and safety of the new drug-eluting stent (DES), as compared with the first- and second-generation DES, in the "real world" daily practice.

  Eligibility

Ages Eligible for Study:   18 Years and older
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, PhD 2-3010-4812 ext 82 sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD, PhD 2-3010-3995 ext 82 dwpark@amc.seoul.kr

  Hide Study Locations
Locations
Korea, Republic of
Sejong General Hospital Recruiting
Bucheon, Korea, Republic of
Contact: Jin-Sik Park, MD,PhD         
Principal Investigator: Jin-Sik Park, MD,PhD         
Soonchunhyang University Hospital, Buchen Recruiting
Bucheon, Korea, Republic of
Contact: Nae-Hee Lee, MD,PhD         
Principal Investigator: Nae-Hee Lee, MD,PhD         
Busan Paik Hospital Recruiting
Busan, Korea, Republic of
Contact: Tae-Hyun Yang, MD, PhD         
Principal Investigator: Tae-Hyun Yang, MD, PhD         
Samsung Changwon Hospital Recruiting
Changwon, Korea, Republic of
Contact: Joo-Hyun Oh, MD,PhD         
Principal Investigator: Joo-Hyun Oh, MD,PhD         
Soonchunhyang University Cheonan Hospital Recruiting
Cheonan, Korea, Republic of
Contact: Won-Yong Shin, MD,PhD         
Principal Investigator: Won-Yong Shin, MD, PhD         
Dankook University Hospital Recruiting
Cheonan, Korea, Republic of
Contact: Byung-Eun Park, MD,PhD         
Principal Investigator: Byung-Eun Park, MD,PhD         
Cheongju Saint Mary's Hospital Recruiting
Cheongju, Korea, Republic of
Contact: Yong-Mo Yang, MD         
Sub-Investigator: Yong-Mo Yang, MD         
Kangwon National University Hospital Recruiting
Chooncheon, Korea, Republic of
Contact: Bong-Ki Lee         
Principal Investigator: Bong-Ki Lee, MD,PhD         
Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Jong-Sun Park, MD,PhD         
Principal Investigator: Jong-Sun Park, MD,PhD         
Daegu Catholic University Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Kee-Sik Kim, MD, PhD         
Principal Investigator: Kee-Sik Kim, MD, PhD         
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Seung-Ho Hur, MD,PhD         
Principal Investigator: Seung-Ho Hur, MD,PhD         
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of
Contact: Hun Sik Park         
Principal Investigator: Hun-Sik Park, MD,PhD         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Jin-Ok Jeong, MD, PhD         
Principal Investigator: Jin-Ok Jeong, MD, PhD         
Daejeon St Mary's Hospital Catholic University Recruiting
Daejeon, Korea, Republic of
Contact: Sung-Ho Her, MD         
Principal Investigator: Sung-Ho Her, MD         
Eulji University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Yoo-Jung Choi, MD,PhD         
Principal Investigator: Yoo-Jung Choi, MD,PhD         
GonYang University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Jang-Ho Bae, MD,PhD         
Principal Investigator: Jang-Ho Bae, MD,PhD         
Asan Medical Center Recruiting
GangNeung, Korea, Republic of
Contact: Sang-Sig Cheong, MD, PhD         
Principal Investigator: Sang-Sig Cheong, MD, PhD         
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Myung Ho Jung, MD,PhD         
Principal Investigator: Myung Ho Jung, MD,PhD         
Gwangju Christian Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Seung Uk Lee, MD, PhD         
Principal Investigator: Seung Uk Lee, MD, PhD         
DongGuk University Gyongju Hospital Recruiting
Gyongju, Korea, Republic of
Contact: Deuk Young Nah, MD, PhD         
Principal Investigator: Deuk Young Nah, MD, PhD         
Inje University Ilsan Paik Hospital Recruiting
Ilsan, Korea, Republic of
Contact: Sung-Yoon Lee, MD,PhD         
Principal Investigator: Sung-Yoon Lee, MD,PhD         
NHIC Ilsan Hospital Recruiting
Ilsan, Korea, Republic of
Contact: Joo-Joung Yang, MD, PhD         
Principal Investigator: Joo-Young Yang, MD, PhD         
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of
Contact: Tae-Hoon Ahn, MD,PhD         
Principal Investigator: Tae-Hoon Ahn, MD,PhD         
Inha University Hospital Recruiting
Incheon, Korea, Republic of
Contact: Geum-Soo Park, MD,PhD         
Principal Investigator: Geum-Soo Park, MD,PhD         
Chonbuk National University Hospital Recruiting
Jeonju, Korea, Republic of
Contact: Jae-Gun Chae, MD,PhD         
Principal Investigator: Jae-Gun Chae, MD, PhD         
Presbyterian Medical Center Recruiting
Jeonju, Korea, Republic of
Contact: Jei-Young Ryu, MD,PhD         
Principal Investigator: Jei-Young Ryu, MD,PhD         
Gyeongsang National University Hospital Recruiting
Jinju, Korea, Republic of
Contact: Yong-Whi Park, MD,PhD         
Principal Investigator: Yong-Whi Park, MD,PhD         
Good Samaritan Hospital Recruiting
Pohang, Korea, Republic of
Contact: Yong-Suk Jeong, MD,PhD         
Principal Investigator: Yong-Seok Jeong, MD,PhD         
Dong-A University Medical Center Recruiting
Pusan, Korea, Republic of
Contact: Moo Hyun Kim         
Principal Investigator: Moo-Hyun Kim, MD,PhD         
Pusan National University Yangsan Hospital Recruiting
Pusan, Korea, Republic of
Contact: Jun Hong Kim         
Principal Investigator: Jun-Hong Kim, MD,PhD         
Hallym University Sacred Heart Hospital, Recruiting
PyeongChon, Korea, Republic of
Contact: Woo-Jung Park, MD, PhD         
Principal Investigator: Woo-Jung Park, MD, PhD         
Bundang Cha Hospical Recruiting
Seongnam, Korea, Republic of
Contact: Sang-Wook Lim, MD,PhD         
Principal Investigator: Sang-Wook Lim, MD,PhD         
Hangang Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of
Contact: Min-Kyu Kim, MD, PhD         
Principal Investigator: Min-Kyu Kim, MD, PhD         
Catholic University, Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ki-Bae Seung, MD,PhD         
Ewha Women University Mokdong Hospital Recruiting
Seoul, Korea, Republic of
Contact: Si-Hoon Park         
Principal Investigator: Si-Hoon Park, MD,PhD         
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyuk-Moon Kwon, MD,PhD         
Principal Investigator: Hyuk-Moon Kwon, MD, PhD         
The Catholic University of Korea Yeouido St.Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yun-Seok Choi, MD,PhD         
Principal Investigator: Yun-Seok Choi, MD,PhD         
KangBuk Samsung Hospital Recruiting
Seoul, Korea, Republic of
Contact: Byung-Jin Kim, MD,PhD         
Principal Investigator: Byung-Jin Kim, MD,PhD         
Kangdong Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kyu-Rok Han, MD,PhD         
Principal Investigator: Kyu-Rok Han, MD,PhD         
Kangnam Secred Heart Hospital Recruiting
Seoul, Korea, Republic of
Contact: Nam-Ho Lee, MD,PhD         
Principal Investigator: Nam-Ho Lee, MD,PhD         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Do-Sun Lim, MD, PhD         
Principal Investigator: Do-Sun Lim, MD,PhD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung-Jung Park, MD, PhD    (82-2)-3010-4812    sjpark@amc.seoul.kr   
Principal Investigator: Seung-Jung Park, MD, PhD         
Korea Veterans Hospital Recruiting
Seoul, Korea, Republic of
Contact: Geun Lee, MD,PhD         
Principal Investigator: Geun Lee, MD,PhD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyo-Soo Kim, MD,PhD         
Principal Investigator: Hyo-Soo Kim, MD,PhD         
SMG-SNU Boramae Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jae-Bin Suh, MD,PhD         
Principal Investigator: Jae-Bin Suh, MD,PhD         
The Catholic University of Korea St.Paul's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Dong-Bin Kim, MD,PhD         
Principal Investigator: Dong-Bin Kim, MD,PhD         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seung-Woon Rha, MD,PhD         
Principal Investigator: Seung-Woon Rha, MD,PhD         
St.Carollo Hospital Recruiting
Suncheon, Korea, Republic of
Contact: Jang-Hyun Cho, MD,PhD         
Principal Investigator: Jang-Hyun Cho, MD,PhD         
Ajou University Medical Center Recruiting
Suwon, Korea, Republic of
Contact: Seung-Jae Tahk, MD,PhD         
Principal Investigator: Seung-Jae Tahk, MD,PhD         
The Catholic University of Korea St.Vincent's Hospital Recruiting
Suwon, Korea, Republic of
Contact: Gun-Woong Moon, MD,PhD         
Principal Investigator: Gun-Woong Moon, MD,PhD         
The Catholic University of Korea Uijeongbu St.Mary's Hospital Recruiting
Uijeongbu, Korea, Republic of
Contact: Jong-Min Lee, MD,PhD         
Principal Investigator: Jong-Min Lee, MD,PhD         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Sang-Gon Lee, MD, PhD         
Principal Investigator: Sang-Gon Lee, MD, PhD         
Wonju Christian Hospital Recruiting
Wonju, Korea, Republic of
Contact: Jung-Han Yoon, MD,PhD         
Principal Investigator: Jung-Han Yoon, MD,PhD         
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park Asan Medical Center
  More Information

No publications provided

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: November 22, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:
coronary disease
stents

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

ClinicalTrials.gov processed this record on November 25, 2014