Registry to Evaluate Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting

EXCELLENT (Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing) Registry

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

The investigators will compare EES (Xience/Promus, prospective arm) with sirolimus-eluting stent (SES, Cypher, retrospective arm).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Xience/Promus; Device: Cypher

• Study Type: Observational
• Enrollment (Actual): 3056

Contacts and Locations

Study Locations

• South Korea
  • Cheonan, South Korea
    • Soon Chun Hyang University Hospital Cheonan
  • Cheonan, South Korea
    • Dankook University Hospital
  • Cheongju-si, South Korea
    • Chungbuk National University Hospital
  • Gwangju, South Korea
    • Kwangju Veterans Hospital
  • Iksan, South Korea
    • Wonkwang University Hospital
  • Iksan, South Korea
    • Chonbuk National University Hospital
  • Ilsan, South Korea
    • Inje University Ilsan Paik Hospital
  • Inchon, South Korea
    • Gachon Kil Medical Center
  • Jeonju, South Korea
    • Presbyterian Medical Center
  • Jinju, South Korea
    • Gyeongsang National University Hospital
  • Pusan, South Korea
    • Inje University Pusan Paik Hospital
  • Seongnam, South Korea
    • Seoul National University Bundang Hospital
  • Seoul, South Korea
    • Samsung Medical Center
  • Seoul, South Korea
    • Seoul National University Hospital
  • Seoul, South Korea
    • Gangnam Severance Hospital
  • Seoul, South Korea
    • Kyung Hee University Medical Center
  • Seoul, South Korea
    • Yonsei University Medical Center
  • Suncheon, South Korea
    • St. Carollo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Xience/Promus; Active prospective registration of patients receiving everolimus eluting stent	Device: Xience/Promus; Active prospective registration of patients receiving everolimus-eluting stent; Other Names: EES
Cypher; Retrospective historical controls that received sirolimus-eluting stent	Device: Cypher; Retrospective historical controls that received sirolimus-eluting stent; Other Names: SES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Boston Scientific Corporation; Abbott
• Investigators: Study Chair: Hyo-Soo Kim, MD,PhD, Seoul National University Hospital

Publications and helpful links

General Publications

• Lee JM, Hahn JY, Kang J, Park KW, Chun WJ, Rha SW, Yu CW, Jeong JO, Jeong MH, Yoon JH, Jang Y, Tahk SJ, Gwon HC, Koo BK, Kim HS. Differential Prognostic Effect Between First- and Second-Generation Drug-Eluting Stents in Coronary Bifurcation Lesions: Patient-Level Analysis of the Korean Bifurcation Pooled Cohorts. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1318-1331. doi: 10.1016/j.jcin.2015.05.014.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2008
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: August 14, 2009
• First Submitted That Met QC Criteria: August 17, 2009
• First Posted (Estimated): August 18, 2009

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Drug eluting stent; Everolimus; Sirolimus
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: EXCELLENT-REGISTRY