EXCEL Clinical Trial (Universal Registry)

Coronary Artery Disease Clinical Trial

— EXCEL  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01205789
• Other study ID #: 10-389 UR
• 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

Related Conditions & MeSH terms

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

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