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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01205789
Other study ID # 10-389 UR
Secondary ID
Status Completed
Phase N/A
First received September 16, 2010
Last updated November 30, 2012
Start date October 2010
Est. completion date September 2012

Study information

Verified date November 2012
Source Abbott Vascular
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States Abbott Vascular Santa Clara California

Sponsors (1)

Lead Sponsor Collaborator
Abbott Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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