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EXCEL Clinical Trial (Universal Registry) (EXCEL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01205789
First Posted: September 20, 2010
Last Update Posted: December 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abbott Vascular
  Purpose
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
Chronic Coronary Occlusion Left Main Coronary Artery Disease Stent Thrombosis Vascular Disease Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • 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.



Enrollment: 1000
Study Start Date: October 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Universal Registry
Subjects who are either not eligible for randomization or for other reasons are not randomized will be consented for the Universal Registry

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: September 16, 2010
First Posted: September 20, 2010
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