EXCEL Clinical Trial (Universal Registry)
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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 |
|---|
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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 |
- 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 ] [ Designated as safety issue: No ]
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 |
|---|
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Universal Registry
Subjects who are either not eligible for randomization or for other reasons are not randomized will be consented for the Universal Registry
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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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Approximately 1000 consecutive subjects enrolled which includes approximately 100 consecutive subjects with intermediate lesions
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| United States, California | |
| Abbott Vascular | |
| Santa Clara, California, United States, 95054 | |
| 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
No publications provided
| Responsible Party: | Abbott Vascular |
| ClinicalTrials.gov Identifier: | NCT01205789 History of Changes |
| Other Study ID Numbers: | 10-389 UR |
| Study First Received: | September 16, 2010 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
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 Occlusion Coronary Stenosis |
Coronary Restenosis Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes Embolism and Thrombosis |
ClinicalTrials.gov processed this record on May 22, 2013