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EXCEL Clinical Trial (Universal Registry) (EXCEL)

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ClinicalTrials.gov Identifier: NCT01205789
Recruitment Status : Completed
First Posted : September 20, 2010
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):

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
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 : October 2010
Primary Completion Date : September 2012
Study Completion Date : September 2012
Groups and Cohorts

Group/Cohort
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 :
  1. 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.



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 1000 consecutive subjects enrolled which includes approximately 100 consecutive subjects with intermediate lesions
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01205789


Locations
United States, California
Abbott Vascular
Santa Clara, California, United States, 95054
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Gregg W Stone, MD Columbia University
Principal Investigator: Patrick W Serruys, MD Erasmus Medical Center
Principal Investigator: Joseph Sabik, MD Cleveland Clinical Main Campus
Principal Investigator: A. Pieter Kappetein, MD Erasmus Medical Center
More Information

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01205789     History of Changes
Other Study ID Numbers: 10-389 UR
First Posted: September 20, 2010    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: November 2012

Keywords provided by Abbott Vascular:
Drug eluting stents
Stents
Angioplasty
Left Main Coronary Artery Disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Thrombosis
Vascular Diseases
Coronary Stenosis
Coronary Restenosis
Coronary Occlusion
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Embolism and Thrombosis