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Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent

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ClinicalTrials.gov Identifier: NCT00960908
Recruitment Status : Unknown
Verified August 2009 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : August 18, 2009
Last Update Posted : August 18, 2009
Sponsor:
Collaborator:
Medtronic
Information provided by:
Seoul National University Hospital

Brief Summary:

The objective of this study is to evaluate the safety and long-term effectiveness of coronary stenting with the zotarolimus eluting stent (ZES) and to determine clinical device and procedural success during commercial use of ZES.

The investigators will compare 2nd generation ZE (Endeavor resolute, active prospective arm) with 1st generation ZES (Endeavor Sprint, retrospective arm).


Condition or disease Intervention/treatment
Coronary Artery Disease Device: Endeavor Resolute stents Device: Endeavor Sprint stent

Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: RESOLUTE-KOREA Registry - Registry to Evaluate the Efficacy of Zotarolimus-eluting Stent
Study Start Date : January 2009
Estimated Primary Completion Date : January 2012

Group/Cohort Intervention/treatment
Resolute
Prospective recruitment of Resolute arm will start in March 2009
Device: Endeavor Resolute stents
2nd generation ZES
Other Name: Endeavor Resolute

Endeavor
The retrospective recruiting period of Endeavor arm comprises a fixed 2-year time between January 2006 and December 2008. The patients, who were treated with Endeavor in that period, will be enrolled if they agree to participate in this study.
Device: Endeavor Sprint stent
1st generation ZES
Other Name: Endeavor Sprint




Primary Outcome Measures :
  1. Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. In-stent & In-segment Late Loss [ Time Frame: 9 months ]
  2. Stent Thrombosis [ Time Frame: 1 year ]
  3. Target Vessel Failure (composite of cardiac death, MI, and TVR) [ Time Frame: 12 months ]
  4. Any death, cardiac death, MI, TLR, TVR [ Time Frame: 1 year ]
  5. Composite rate of cardiac death and any MI [ Time Frame: 1 year ]
  6. Composite rate of all death and any MI [ Time Frame: 1 year ]
  7. Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization [ Time Frame: 1 year ]
  8. Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy [ Time Frame: 1 year ]
  9. Clinical device and procedural success [ Time Frame: During the health care facility stay ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 4000 patients derived from a population of patients receiving percutaneous coronary intervention for ischemic heart disease will be enrolled in the present registry.
Criteria

Inclusion Criteria:

  • The patient agrees to participate in this study by signing the informed consent form.
  • Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.

Exclusion Criteria:

  • There are no exclusion criteria for this registry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960908


Contacts
Contact: Kyung-Woo Park, MD, PhD 82-2-2072-0244 kwparkmd@snu.ac.kr
Contact: Il-Young Oh, MD 82-2-2072-3757 spy510@snu.ac.kr

Locations
Korea, Republic of
Hallym University Sacred Heart Hospital Not yet recruiting
Anyang, Korea, Republic of
Contact: Young-Jin Choi, MD,PhD       cyj@hallym.or.kr   
Principal Investigator: Young-Jin Choi, MD,PhD         
Yongnam University Medical Center Not yet recruiting
Daegu, Korea, Republic of
Contact: Jong-Sun Park, MD,PhD       pjs@medical.yu.ac.kr   
Principal Investigator: Jong-Sun Park, MD,PhD         
Chungnam National University Hospital Not yet recruiting
Daejeon, Korea, Republic of
Contact: In-Whan Seong, MD,PhD       iwseong@cnu.ac.kr   
Principal Investigator: In-Hwan Seong, MD,PhD         
Chonbuk National Univesity Hospital Not yet recruiting
Iksan, Korea, Republic of
Contact: Jae-Keon Chae, MD,PhD       jkchae@chonbuk.ac.kr   
Principal Investigator: Jae-Keon Chae, MD,PhD         
Inje University Ilsan Paik Hospital Not yet recruiting
Ilsan, Korea, Republic of
Contact: Seong-Yoon Lee, MD,PhD       im2pci@gmail.com   
Principal Investigator: Seong-Yoon Lee, MD,PhD         
National Health Insurance Corporation Ilsan Hospital Recruiting
Ilsan, Korea, Republic of
Contact: Dong-Woon Chun, MD,PhD       jdw12162000@yahoo.co.kr   
Principal Investigator: Dong-Woon Chun, MD,PhD         
Gachon Kil Medical Center Not yet recruiting
Inchon, Korea, Republic of
Contact: Tae-Hoon Ahn, MD,PhD       encore@gilhospital.com   
Principal Investigator: Tae-Hoon Ahn, MD,PhD         
Inha University Hospital Recruiting
Inchon, Korea, Republic of
Contact: Seong-Il Woo, MD,PhD       wjswgs@naver.com   
Principal Investigator: Seong-Il Woo, MD,PhD         
Gyeongsang National University Hospital Not yet recruiting
Jinju, Korea, Republic of
Contact: Jin-Yong Hwang, MD,PhD       jyhwang@gnu.ac.kr   
Principal Investigator: Jin-Yong Hwang, MD,PhD         
Pusan National University Hospital Not yet recruiting
Pusan, Korea, Republic of
Contact: Han-Cheol Lee, MD,PhD       glaraone@hanmail.net   
Principal Investigator: Han-Cheol Lee, MD,PhD         
Bundang CHA Medical Center Not yet recruiting
Seongnam, Korea, Republic of
Contact: Seong-Wook Lim, MD,PhD       swlim@cha.ac.kr   
Principal Investigator: Seong-Wook Lim, MD,PhD         
Seoul National University Bundang Hospital Not yet recruiting
Seongnam, Korea, Republic of
Contact: Dong-Ju Choi, MD,PhD       djchoi@snu.ac.kr   
Principal Investigator: Dong-Ju Choi, MD,PhD         
Gangbuk Samsung Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Jin-Ho Kang, MD,PhD       jinho2.kang@samsung.com   
Principal Investigator: Jin-Ho Kang, MD,PhD         
Kangdong Sacred Heart Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Kyoo-Rok Han, MD,PhD       krheart@hallym.or.kr   
Principal Investigator: Kyoo-Rok Han, MD,PhD         
Seoul Boramae Hospital Recruiting
Seoul, Korea, Republic of
Contact: Sang-Hyun Kim, MD,PhD       shkimmd@snu.ac.kr   
Principal Investigator: Sang-Hyun Kim, MD,PhD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kyung-Woo Park, MD,PhD       kwparkmd@snu.ac.kr   
Principal Investigator: Hyo-Soo Kim, MD,PhD         
Soonchunhyang University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Min-Soo Hyon, MD,PhD       mshyon@hosp.sch.ac.kr   
Principal Investigator: Min-Soo Hyon, MD,PhD         
St. Vincent's Hospital Not yet recruiting
Suwon, Korea, Republic of
Contact: Geon-Woong Moon, MD,PhD       cardiomoon@gmail.com   
Principal Investigator: Geon-Woong Moon, MD,PhD         
Uijeongbu St. Mary's Hospital Not yet recruiting
Uijeongbu, Korea, Republic of
Contact: Hee-Kyung Jeon, MD,PhD       jhkmht@catholic.ac.kr   
Principal Investigator: Hee-Kyung Jeon, MD,PhD         
Sponsors and Collaborators
Seoul National University Hospital
Medtronic
Investigators
Study Chair: Hyo-Soo Kim, MD, PhD Seoul National University Hospital

Responsible Party: Hyo-Soo Kim, MD, PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00960908     History of Changes
Other Study ID Numbers: RESOLUTE-KOREA
First Posted: August 18, 2009    Key Record Dates
Last Update Posted: August 18, 2009
Last Verified: August 2009

Keywords provided by Seoul National University Hospital:
Zotarolimus
Drug eluting stent
Endeavor Resolute

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