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CompletedNCT00731237EXCEEDUpdated Oct 16, 2009

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

An observational study in Atherosclerosis and Coronary Artery Disease, sponsored by Abbott Medical Devices. Completed at 44 sites in United States. Per ClinicalTrials.gov, last updated 2009-10-16.

Sponsored by Abbott Medical Devices · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,517
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Atherosclerosis
  • Coronary Artery Disease

Keywords

  • Drug Eluting Stent
  • Percutaneous Coronary Intervention
  • Everolimus
03

In context

Coronary Artery Disease

5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's enrollment of 2,517 is above the median of 336 across 1,946 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,517 participants (actual)

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Overall physician-determined XIENCE V® EECSS acute performance and deliverability.

    Time frame: acute

  2. Physician-determined procedure success

    Time frame: acute

Secondary outcomes

  1. Individual component of adjunctive devices and drugs used during procedure. Number and type of guide wires

    Time frame: acute

  2. Individual component of adjunctive devices and drugs used during procedure. Number and type of guiding catheters

    Time frame: acute

  3. Individual component of adjunctive devices and drugs used during procedure. Number and type of balloon dilation catheters

    Time frame: acute

  4. Individual component of adjunctive devices and drugs used during procedure: Balloon pressures (pre-dilation/post-dilation pressures)

    Time frame: acute

  5. Individual component of adjunctive devices and drugs used during procedure: Number of stents

    Time frame: acute

  6. Individual component of adjunctive devices and drugs used during procedure: Amount of radiographic contrast

    Time frame: acute

  7. Individual component of adjunctive devices and drugs used during procedure: Fluoroscopy time

    Time frame: acute

  8. Individual component of adjunctive devices and drugs used during procedure: Duration of PCI procedure

    Time frame: acute

  9. Individual component of adjunctive devices and drugs used during procedure: IVUS use

    Time frame: acute

  10. Individual component of adjunctive devices and drugs used during procedure: Thienopyridine loading dose (prior to, during or after procedure)

    Time frame: acute

  11. Individual component of adjunctive devices and drugs used during procedure: Aspirin loading dose (prior to, during or after procedure)

    Time frame: acute

  12. Device Success

    Time frame: acute

07

Study locations

44 sites
  • The Heart Center, PC
    Huntsville, Alabama 35801, United States
  • Arizona Regional Medical Center
    Mesa, Arizona 85206, United States
  • Tri Lakes Research-Central Arkansas Cardiovascular
    Hot Springs National Park, Arkansas 71913, United States
  • Tri Lakes Research-Central Arkansas Cardiovascular
    Hot Springs Village, Arkansas 71909, United States
  • NEA Baptist Memorial Hospital
    Jonesboro, Arkansas 72401, United States
  • La Mesa Cardiac Center
    La Mesa, California 91942, United States
  • Pikes Peak Cardiology
    Colorado Springs, Colorado 80907, United States
  • University of Connecticut Health Center
    Farmington, Connecticut 06030, United States
  • Bradenton Heart Research Center
    Bradenton, Florida 34209, United States
  • Ocala Regional Medical Center
    Ocala, Florida 34471, United States
  • Harbin Clinic LLC
    Rome, Georgia 30165, United States
  • Sherman Hospital
    Elgin, Illinois 60120, United States
  • Heart Care Research Foundation
    Mokena, Illinois 60448, United States
  • Northern Indiana Research Alliance
    Fort Wayne, Indiana 46804, United States
  • Clarian Health Partners - Methodist Hospital
    Indianapolis, Indiana 46202, United States
  • Medical Consultants PC
    Muncie, Indiana 47303, United States
  • Iowa Heart Center
    Des Moines, Iowa 50314, United States
  • University of Iowa Hospital
    Iowa City, Iowa 52242, United States
  • Promise Regional Medical Center - Hutchinson
    Hutchinson, Kansas 67502, United States
  • Allegiance Health
    Jackson, Michigan 49201, United States
  • Michigan Cardiovascular Institute
    Midland, Michigan 48670, United States
  • Michigan Cardio Vascular Institute at St. Mary's of MI
    Saginaw, Michigan 48601, United States
  • Coast Cardiovascular Consultants, P.L.L.C
    Biloxi, Mississippi 39501, United States
  • St. Luke's
    Kansas City, Missouri 64111, United States
  • St. Johns Mercy Medical Center
    St. Louis, Missouri 63141, United States
  • Renown Regional Medical Center
    Reno, Nevada 89502, United States
  • AtlantiCare Regional Medical Center
    Pomona, New Jersey 08240, United States
  • University of New Mexico Health Sciences Center
    Albuquerque, New Mexico 87131, United States
  • First Health Moore Regional Hospital
    Pinehurst, North Carolina 28374, United States
  • Fairfield Cardiac Cath Lab, LLC
    Fairfield, Ohio 45014, United States
  • Smith Clinic
    Marion, Ohio 43302, United States
  • St. Anthony Hospital
    Oklahoma City, Oklahoma 73102, United States
  • Conemaugh Valley Memorial Hospital
    Johnstown, Pennsylvania 15905, United States
  • The Good Samaritan Hospital
    Lebanon, Pennsylvania 17042, United States
  • Phoenixville Hospital
    Phoenixville, Pennsylvania 19460, United States
  • University Pittsburgh Medical Center (UPMC)
    Pittsburgh, Pennsylvania 15213, United States
  • UPMC Presbyterian Shadyside Hospital
    Pittsburgh, Pennsylvania 15232, United States
  • Palmetto Health Clinic
    Columbia, South Carolina 29210, United States
  • Piedmont Medical Center / Carolina Cardiology Associates
    Rock Hill, South Carolina 29732, United States
  • Wellmont Bristol Regional Medical Center
    Bristol, Tennessee 37620, United States
  • Tomball Regional Medical Center
    Tomball, Texas 77375, United States
  • Virginia Cardiovascular Specialists
    Richmond,, Virginia 23225, United States
  • Cardiovascular Associates, Ltd.
    Virginia Beach,, Virginia 23454, United States
  • CAMC Health Education and Research Institute, Inc.
    Charleston, West Virginia 25304, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00731237
Lead sponsor
Abbott Medical Devices
First posted
Aug 8, 2008
Start date
Oct 2008
Primary completion
Mar 2009
Completion
Oct 2009
Last update
Oct 16, 2009

Study contacts

John McPherson, MD
principal investigator · Vanderbuilt University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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