XIENCE V® EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery (EXCEED)

October 15, 2009 updated by: Abbott Medical Devices

XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery

This trial is to assess physician-determined XIENCE V® EECSS acute performance, deliverability and resource utilization in the catheterization lab during commercial use by various physicians with a range of coronary stenting experience

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This study will evaluate overall physician-determined XIENCE V® Everolimus Eluting Coronary Stent system (XIENCE V®) acute performance, deliverability and resource utilization in the catheterization lab in the "real world" as used by a broad group of physicians at a variety of health care facilities. This study will include all consecutively enrolled patients in the United States of America (USA) who consent to participate and receive XIENCE V® stents.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2517

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • The Heart Center, PC
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Arizona Regional Medical Center
    • Arkansas
      • Hot Springs National Park, Arkansas, United States, 71913
        • Tri Lakes Research-Central Arkansas Cardiovascular
      • Hot Springs Village, Arkansas, United States, 71909
        • Tri Lakes Research-Central Arkansas Cardiovascular
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Memorial Hospital
    • California
      • La Mesa, California, United States, 91942
        • La Mesa Cardiac Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Pikes Peak Cardiology
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • University of Connecticut Health Center
    • Florida
      • Bradenton, Florida, United States, 34209
        • Bradenton Heart Research Center
      • Ocala, Florida, United States, 34471
        • Ocala Regional Medical Center
    • Georgia
      • Rome, Georgia, United States, 30165
        • Harbin Clinic LLC
    • Illinois
      • Elgin, Illinois, United States, 60120
        • Sherman Hospital
      • Mokena, Illinois, United States, 60448
        • Heart Care Research Foundation
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Northern Indiana Research Alliance
      • Indianapolis, Indiana, United States, 46202
        • Clarian Health Partners - Methodist Hospital
      • Muncie, Indiana, United States, 47303
        • Medical Consultants PC
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Iowa Heart Center
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital
    • Kansas
      • Hutchinson, Kansas, United States, 67502
        • Promise Regional Medical Center - Hutchinson
    • Michigan
      • Jackson, Michigan, United States, 49201
        • Allegiance Health
      • Midland, Michigan, United States, 48670
        • Michigan Cardiovascular Institute
      • Saginaw, Michigan, United States, 48601
        • Michigan Cardio Vascular Institute at St. Mary's of MI
    • Mississippi
      • Biloxi, Mississippi, United States, 39501
        • Coast Cardiovascular Consultants, P.L.L.C
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's
      • St. Louis, Missouri, United States, 63141
        • St. Johns Mercy Medical Center
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Regional Medical Center
    • New Jersey
      • Pomona, New Jersey, United States, 08240
        • AtlantiCare Regional Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Health Sciences Center
    • North Carolina
      • Pinehurst, North Carolina, United States, 28374
        • First Health Moore Regional Hospital
    • Ohio
      • Fairfield, Ohio, United States, 45014
        • Fairfield Cardiac Cath Lab, Llc
      • Marion, Ohio, United States, 43302
        • Smith Clinic
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • St. Anthony Hospital
    • Pennsylvania
      • Johnstown, Pennsylvania, United States, 15905
        • Conemaugh Valley Memorial Hospital
      • Lebanon, Pennsylvania, United States, 17042
        • The Good Samaritan Hospital
      • Phoenixville, Pennsylvania, United States, 19460
        • Phoenixville Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University Pittsburgh Medical Center (UPMC)
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Presbyterian Shadyside Hospital
    • South Carolina
      • Columbia, South Carolina, United States, 29210
        • Palmetto Health Clinic
      • Rock Hill, South Carolina, United States, 29732
        • Piedmont Medical Center / Carolina Cardiology Associates
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Wellmont Bristol Regional Medical Center
    • Texas
      • Tomball, Texas, United States, 77375
        • Tomball Regional Medical Center
    • Virginia
      • Richmond,, Virginia, United States, 23225
        • Virginia Cardiovascular Specialists
      • Virginia Beach,, Virginia, United States, 23454
        • Cardiovascular Associates, Ltd.
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Health Education and Research Institute, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing planned or possible PCI should be invited to participate in the study.

Description

General Inclusion Criteria:

  • The patient agrees to participate in this study by signing the IRB approved informed consent form prior to the index procedure.
  • Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form prior to the index procedure.

General Exclusion Criteria:

  • Inability to obtain an informed consent is an exclusion criterion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
1
The procedures undergone by this group will be evaluated for: Acute performance, deliverability and resource utilization during the procedure in the catheterization lab during commercial use by various physicians with a range of coronary stenting experience.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall physician-determined XIENCE V® EECSS acute performance and deliverability.
Time Frame: acute
acute
Physician-determined procedure success
Time Frame: acute
acute

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Individual component of adjunctive devices and drugs used during procedure. Number and type of guide wires
Time Frame: acute
acute
Individual component of adjunctive devices and drugs used during procedure. Number and type of guiding catheters
Time Frame: acute
acute
Individual component of adjunctive devices and drugs used during procedure. Number and type of balloon dilation catheters
Time Frame: acute
acute
Individual component of adjunctive devices and drugs used during procedure: Balloon pressures (pre-dilation/post-dilation pressures)
Time Frame: acute
acute
Individual component of adjunctive devices and drugs used during procedure: Number of stents
Time Frame: acute
acute
Individual component of adjunctive devices and drugs used during procedure: Amount of radiographic contrast
Time Frame: acute
acute
Individual component of adjunctive devices and drugs used during procedure: Fluoroscopy time
Time Frame: acute
acute
Individual component of adjunctive devices and drugs used during procedure: Duration of PCI procedure
Time Frame: acute
acute
Individual component of adjunctive devices and drugs used during procedure: IVUS use
Time Frame: acute
acute
Individual component of adjunctive devices and drugs used during procedure: Thienopyridine loading dose (prior to, during or after procedure)
Time Frame: acute
acute
Individual component of adjunctive devices and drugs used during procedure: Aspirin loading dose (prior to, during or after procedure)
Time Frame: acute
acute
Device Success
Time Frame: acute
acute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John McPherson, MD, Vanderbuilt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 08-382

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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