Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial (RESET)
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Purpose
The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Device: Everolimus-eluting stent Device: Sirolimus-eluting stent |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial |
- target-lesion revascularization [ Time Frame: 1-year ] [ Designated as safety issue: No ]
- all-cause death or myocardial infarction [ Time Frame: 3-year ] [ Designated as safety issue: No ]
- all-cause death [ Time Frame: 3-year ] [ Designated as safety issue: No ]
- cardiac death [ Time Frame: 3-year ] [ Designated as safety issue: No ]
- myocardial infarction [ Time Frame: 3-year ] [ Designated as safety issue: No ]
- stent thrombosis (Academic Research Consortium definition) [ Time Frame: 3-year ] [ Designated as safety issue: No ]
- ischemic and hemorrhagic strokes excluding transient ischemic attacks and secondary causes [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
- bleeding complications (GUSTO and TIMI definition) [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
- stent deployment success [ Time Frame: at implantation ] [ Designated as safety issue: No ]
- procedure time [ Time Frame: at implantation ] [ Designated as safety issue: No ]
- clinically-driven target-lesion revascularization [ Time Frame: 3-year ] [ Designated as safety issue: No ]
- non-target-lesion revascularization [ Time Frame: 3-year ] [ Designated as safety issue: No ]
- coronary artery bypass grafting [ Time Frame: 3-year ] [ Designated as safety issue: No ]
- target-vessel revascularization [ Time Frame: 3-year ] [ Designated as safety issue: No ]
- any repeat coronary revascularization [ Time Frame: 3-year ] [ Designated as safety issue: No ]
- composite of cardiac death, myocardial infarction in the territory of the target vessel or target-lesion revascularization [ Time Frame: 3-year ] [ Designated as safety issue: No ]
- composite of all-cause death, any myocardial infarction or any repeat coronary revascularization [ Time Frame: 3-year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 3200 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Everolimus-eluting stent |
Device: Everolimus-eluting stent
Everolimus-eluting stent
|
| Active Comparator: Sirolimus-eluting stent |
Device: Sirolimus-eluting stent
Sirolimus-eluting stent
|
Detailed Description:
Sirolimus-eluting stent is the most widely used coronary drug-eluting stent in Japan. Everolimus-eluting stent is a new coronary drug-eluting stent, which is going to be approved in the first quarter of 2010 by the Japanese Ministry of Health, Labor and Welfare. It has recently been reported that everolimus-eluting stent had lower rate of target-lesion revascularization and stent thrombosis at 1 year as compared with paclitaxel-eluting stent. However, trial results comparing everolimus-eluting stent with sirolimus-eluting stent are largely unknown. The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice. The design of this study is all-comer design enrolling patients scheduled for percutaneous coronary intervention using drug-eluting stents without any exclusion criteria.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients scheduled for percutaneous coronary intervention using drug-eluting stents
Exclusion Criteria:
- None
Contacts and Locations| Japan | |
| Division of Cardiology, Kyoto University Hospital | |
| Kyoto, Japan, 606-8507 | |
| Principal Investigator: | Takeshi Kimura, MD | Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine |
More Information
No publications provided by Kyoto University, Graduate School of Medicine
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Takeshi Morimoto, Professor, Kyoto University, Graduate School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01035450 History of Changes |
| Other Study ID Numbers: | C338 |
| Study First Received: | December 16, 2009 |
| Last Updated: | September 11, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Kyoto University, Graduate School of Medicine:
|
Coronary stent |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Sirolimus Everolimus |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 23, 2013