EXCEL Clinical Trial (Universal Registry)

NCT01205789 | Completed DMC

• 1 other identifier: 10-389 UR
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the Universal Registry is to assess the proportion and reasons for which subjects with angiographically significant ULMCA disease requiring revascularization during the time course of this study are not randomized; to compare the baseline characteristics of subjects; and to assess the variability in randomization eligibility and treatment patterns.

Conditions

Chronic Coronary Occlusion; Left Main Coronary Artery Disease; Stent Thrombosis; Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Keywords

Drug eluting stents; Stents; Angioplasty; Left Main Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• This study has no Primary outcome measure, it is an observational study to collect information on subjects not randomized to the RCT portion of the study.

  The purpose of the Universal Registry is to assess the proportion and reasons for which subjects with angiographically significant ULMCA disease requiring revascularization during the time course of this study are not randomized; to compare the baseline characteristics of subjects; and to assess the variability in randomization eligibility and treatment patterns. There are no follow-up time points for this study.

  At the time of enrollment into the study

Study Arms (1)

Universal Registry

Subjects who are either not eligible for randomization or for other reasons are not randomized will be consented for the Universal Registry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 1000 consecutive subjects enrolled which includes approximately 100 consecutive subjects with intermediate lesions

You may qualify if:

• Subjects who are either not eligible for randomization or for other reasons are not randomized will be consented for the Universal Registry

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott Vascular

Santa Clara, California, 95054, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Vascular Diseases; Myocardial Ischemia; Coronary Stenosis; Coronary Disease; Coronary Restenosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Gregg W Stone, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Patrick W Serruys, MD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Joseph Sabik, MD

  Cleveland Clinical Main Campus

  PRINCIPAL INVESTIGATOR

• A. Pieter Kappetein, MD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 20, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 4, 2012

Record last verified: 2012-11

Locations

US (1)