EXCEL Clinical Trial (Universal Registry)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01205789

Acronym

EXCEL

Enrollment

1000

Registered

2010-09-20

Start date

2010-10-31

Completion date

2012-09-30

Last updated

2012-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed description

Approximately 100 consecutive subjects who otherwise meet all enrollment criteria, will be analyzed separately as intermediate lesion subjects, and will be followed through the time of initial treatment per standard of care with intended PCI, CABG or medical treatment.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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.	At the time of enrollment into 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.

Countries

United States

Outcome results