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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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Approximately 1000 consecutive subjects enrolled which includes approximately 100 consecutive subjects with intermediate lesions
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott Vascular | Santa Clara | California | 95054 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D014652 | Vascular Diseases |
| D017202 | Myocardial Ischemia |
| D023921 | Coronary Stenosis |
| D003327 | Coronary Disease |
| D023903 | Coronary Restenosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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