Coronary Artery DiseaseNCT00960908
Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 19 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Endeavor Resolute stents and Endeavor Sprint stent
- Type of treatment
- Medical device
- How many people
- 4,000 participants
- Where
- 19 sitesSouth Korea
- Study dates
- Jan 2009to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- There are no exclusion criteria for this registry.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
South Korea19 sites, 19 recruiting
- Not yet recruiting
Hallym University Sacred Heart Hospital
Anyang
Young-Jin Choi, MD,PhD, cyj@hallym.or.kr
Young-Jin Choi, MD,PhD
- Not yet recruiting
Yongnam University Medical Center
Daegu
Jong-Sun Park, MD,PhD, pjs@medical.yu.ac.kr
Jong-Sun Park, MD,PhD
- Not yet recruiting
Chungnam National University Hospital
Daejeon
In-Whan Seong, MD,PhD, iwseong@cnu.ac.kr
In-Hwan Seong, MD,PhD
- Not yet recruiting
Chonbuk National Univesity Hospital
Iksan
Jae-Keon Chae, MD,PhD, jkchae@chonbuk.ac.kr
Jae-Keon Chae, MD,PhD
- Not yet recruiting
Inje University Ilsan Paik Hospital
Ilsan
Seong-Yoon Lee, MD,PhD, im2pci@gmail.com
Seong-Yoon Lee, MD,PhD
- Recruiting
National Health Insurance Corporation Ilsan Hospital
Ilsan
Dong-Woon Chun, MD,PhD, jdw12162000@yahoo.co.kr
Dong-Woon Chun, MD,PhD
- Not yet recruiting
Gachon Kil Medical Center
Inchon
Tae-Hoon Ahn, MD,PhD, encore@gilhospital.com
Tae-Hoon Ahn, MD,PhD
- Recruiting
Inha University Hospital
Inchon
Seong-Il Woo, MD,PhD, wjswgs@naver.com
Seong-Il Woo, MD,PhD
- Not yet recruiting
Gyeongsang National University Hospital
Jinju
Jin-Yong Hwang, MD,PhD, jyhwang@gnu.ac.kr
Jin-Yong Hwang, MD,PhD
- Not yet recruiting
Pusan National University Hospital
Pusan
Han-Cheol Lee, MD,PhD, glaraone@hanmail.net
Han-Cheol Lee, MD,PhD
- Not yet recruiting
Bundang CHA Medical Center
Seongnam
Seong-Wook Lim, MD,PhD, swlim@cha.ac.kr
Seong-Wook Lim, MD,PhD
- Not yet recruiting
Seoul National University Bundang Hospital
Seongnam
Dong-Ju Choi, MD,PhD, djchoi@snu.ac.kr
Dong-Ju Choi, MD,PhD
- Not yet recruiting
Gangbuk Samsung Hospital
Seoul
Jin-Ho Kang, MD,PhD, jinho2.kang@samsung.com
Jin-Ho Kang, MD,PhD
- Not yet recruiting
Kangdong Sacred Heart Hospital
Seoul
Kyoo-Rok Han, MD,PhD, krheart@hallym.or.kr
Kyoo-Rok Han, MD,PhD
- Recruiting
Seoul Boramae Hospital
Seoul
Sang-Hyun Kim, MD,PhD, shkimmd@snu.ac.kr
Sang-Hyun Kim, MD,PhD
- Recruiting
Seoul National University Hospital
Seoul
Kyung-Woo Park, MD,PhD, kwparkmd@snu.ac.kr
Hyo-Soo Kim, MD,PhD
- Not yet recruiting
Soonchunhyang University Hospital
Seoul
Min-Soo Hyon, MD,PhD, mshyon@hosp.sch.ac.kr
Min-Soo Hyon, MD,PhD
- Not yet recruiting
St. Vincent's Hospital
Suwon
Geon-Woong Moon, MD,PhD, cardiomoon@gmail.com
Geon-Woong Moon, MD,PhD
- Not yet recruiting
Uijeongbu St. Mary's Hospital
Uijeongbu-si
Hee-Kyung Jeon, MD,PhD, jhkmht@catholic.ac.kr
Hee-Kyung Jeon, MD,PhD
About this study
Official title: RESOLUTE-KOREA Registry - Registry to Evaluate the Efficacy of Zotarolimus-eluting Stent
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).
- Conditions
- Coronary Artery Disease
- Being tested
- Endeavor Resolute stents, Endeavor Sprint stent
- Keywords
- Zotarolimus, Drug eluting stent, Endeavor Resolute
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endeavor Resolute stentsDevice
Also called Endeavor Resolute
2nd generation ZES
Endeavor Sprint stentDevice
Also called Endeavor Sprint
1st generation ZES
| Study group | Role | What they receive |
|---|---|---|
| Resolute | Prospective recruitment of Resolute arm will start in March 2009 Receives: Device: Endeavor Resolute stents | |
| 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. Receives: Device: Endeavor Sprint stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)
Measured: 12 months
Secondary outcomes (9)
In-stent & In-segment Late Loss
Measured: 9 months
Stent Thrombosis
Measured: 1 year
Target Vessel Failure (composite of cardiac death, MI, and TVR)
Measured: 12 months
Any death, cardiac death, MI, TLR, TVR
Measured: 1 year
Composite rate of cardiac death and any MI
Measured: 1 year
Composite rate of all death and any MI
Measured: 1 year
Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization
Measured: 1 year
Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
Measured: 1 year
Clinical device and procedural success
Measured: During the health care facility stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Investigators
- Hyo-Soo Kim, MD, PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960908
- Sponsor's protocol ID
- RESOLUTE-KOREA
- Status last verified
- Aug 2009
- First submitted
- 14 Aug 2009
- Last updated
- 18 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESOLUTE-KOREA Registry - Registry to Evaluate the Efficacy of Zotarolimus-eluting Stent
- ClinicalTrials.gov ID
- NCT00960908
- Acronym / sponsor ID
- RESOLUTE-KOREA
- Conditions
- Coronary Artery Disease
- Keywords
- Zotarolimus, Drug eluting stent, Endeavor Resolute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jan 2009
- Primary completion
- Jan 2012 (estimated)
- First posted
- 18 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resolute | – | Device: Endeavor Resolute stentsProspective recruitment of Resolute arm will start in March 2009 |
| Endeavor | – | Device: Endeavor Sprint stentThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this registry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endeavor Resolute stentsAlso: Endeavor Resolute2nd generation ZES | Device | Resolute |
| Endeavor Sprint stentAlso: Endeavor Sprint1st generation ZES | Device | Endeavor |
Primary outcome
Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)
Time frame: 12 months
9 secondary outcomes
In-stent & In-segment Late Loss
Time frame: 9 months
Stent Thrombosis
Time frame: 1 year
Target Vessel Failure (composite of cardiac death, MI, and TVR)
Time frame: 12 months
Any death, cardiac death, MI, TLR, TVR
Time frame: 1 year
Composite rate of cardiac death and any MI
Time frame: 1 year
Composite rate of all death and any MI
Time frame: 1 year
Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization
Time frame: 1 year
Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
Time frame: 1 year
Clinical device and procedural success
Time frame: During the health care facility stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyo-Soo Kim, MD, PhD study chair
Seoul National University Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 19 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyung-Woo Park, MD, PhD (82-2-2072-0244, kwparkmd@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2009; AzTrials last refreshed its copy on 8 Nov 2026.