EXCEL Clinical Trial (Universal Registry)

Completed

• 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

• Registration Number: NCT01205789
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2010-09-17
• Study First Posted: 2010-09-20
• Study Start: 2010-10
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-30
• Last Update Posted: 2012-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Abbott Vascular; 🇺🇸 Santa Clara, California, United States