EXCEL Clinical Trial (Universal Registry)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01205789
First received: September 16, 2010
Last updated: November 30, 2012
Last verified: November 2012

September 16, 2010
November 30, 2012
October 2010
September 2012   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01205789 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
EXCEL Clinical Trial (Universal Registry)
Not Provided

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Approximately 1000 consecutive subjects enrolled which includes approximately 100 consecutive subjects with intermediate lesions

  • Chronic Coronary Occlusion
  • Left Main Coronary Artery Disease
  • Stent Thrombosis
  • Vascular Disease
  • Myocardial Ischemia
  • Coronary Artery Stenosis
  • Coronary Disease
  • Coronary Artery Disease
  • Coronary Restenosis
Not Provided
Universal Registry
Subjects who are either not eligible for randomization or for other reasons are not randomized will be consented for the Universal Registry
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who are either not eligible for randomization or for other reasons are not randomized will be consented for the Universal Registry
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01205789
10-389 UR
Yes
Abbott Vascular
Abbott Vascular
Not Provided
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
Abbott Vascular
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP