EXCEL Clinical Trial (Universal Registry)

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT01205789

Collaborator

(none)

1,000

Enrollment

Location

Duration (Months)

43.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Coronary Occlusion Left Main Coronary Artery Disease Stent Thrombosis Vascular Disease Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis

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.

Study Design

Study Type:

Observational

Actual Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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.