Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial (RESET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Kyoto University, Graduate School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT01035450
First received: December 16, 2009
Last updated: September 11, 2012
Last verified: September 2012
  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

Resource links provided by NLM:


Further study details as provided by Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • Patients scheduled for percutaneous coronary intervention using drug-eluting stents

Exclusion Criteria:

  • None
  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: NCT01035450

Locations
Japan
Division of Cardiology, Kyoto University Hospital
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Takeshi Morimoto
Investigators
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
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on September 18, 2014