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EXCEL Clinical Trial (Universal Registry)

NCT ID: NCT01205789

Last Updated: 2012-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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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

Keywords

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Drug eluting stents Stents Angioplasty Left Main Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subjects who are either not eligible for randomization or for other reasons are not randomized will be consented for the Universal Registry
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregg W Stone, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Patrick W Serruys, MD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Joseph Sabik, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinical Main Campus

A. Pieter Kappetein, MD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Abbott Vascular

Santa Clara, California, United States

Site Status

Countries

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United States

Other Identifiers

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10-389 UR

Identifier Type: -

Identifier Source: org_study_id