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Clinical Trials/NCT01205789
NCT01205789CompletedNot Applicable

EXCEL Clinical Trial (Universal Registry)

Abbott Medical Devices1 site in 1 country1,000 target enrollmentStarted: October 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,000
Locations
1
Primary Endpoint
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.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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EXCEL Clinical Trial (Universal Registry) | Clinical Trial