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AtherosclerosisEXCEEDNCT00731237

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

An observational study of Atherosclerosis and Coronary Artery Disease, run by Abbott Medical Devices at 44 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Any age
Conditions the study is for
Atherosclerosis, Coronary Artery Disease
How many people
2,517 participants
Where
44 sitesUnited States
Study dates
Oct 2008to Oct 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

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.

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

United States44 sites

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87131

  • Coast Cardiovascular Consultants, P.L.L.C

    Biloxi, Mississippi, 39501

  • Bradenton Heart Research Center

    Bradenton, Florida, 34209

  • Wellmont Bristol Regional Medical Center

    Bristol, Tennessee, 37620

  • CAMC Health Education and Research Institute, Inc.

    Charleston, West Virginia, 25304

  • Pikes Peak Cardiology

    Colorado Springs, Colorado, 80907

  • Palmetto Health Clinic

    Columbia, South Carolina, 29210

  • Iowa Heart Center

    Des Moines, Iowa, 50314

  • Sherman Hospital

    Elgin, Illinois, 60120

  • Fairfield Cardiac Cath Lab, LLC

    Fairfield, Ohio, 45014

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030

  • Northern Indiana Research Alliance

    Fort Wayne, Indiana, 46804

  • Tri Lakes Research-Central Arkansas Cardiovascular

    Hot Springs, Arkansas, 71913

  • Tri Lakes Research-Central Arkansas Cardiovascular

    Hot Springs Village, Arkansas, 71909

  • The Heart Center, PC

    Huntsville, Alabama, 35801

  • Promise Regional Medical Center - Hutchinson

    Hutchinson, Kansas, 67502

  • Clarian Health Partners - Methodist Hospital

    Indianapolis, Indiana, 46202

  • University of Iowa Hospital

    Iowa City, Iowa, 52242

  • Allegiance Health

    Jackson, Michigan, 49201

  • Conemaugh Valley Memorial Hospital

    Johnstown, Pennsylvania, 15905

  • NEA Baptist Memorial Hospital

    Jonesboro, Arkansas, 72401

  • St. Luke's

    Kansas City, Missouri, 64111

  • La Mesa Cardiac Center

    La Mesa, California, 91942

  • The Good Samaritan Hospital

    Lebanon, Pennsylvania, 17042

  • Smith Clinic

    Marion, Ohio, 43302

  • Arizona Regional Medical Center

    Mesa, Arizona, 85206

  • Michigan Cardiovascular Institute

    Midland, Michigan, 48670

  • Heart Care Research Foundation

    Mokena, Illinois, 60448

  • Medical Consultants PC

    Muncie, Indiana, 47303

  • Ocala Regional Medical Center

    Ocala, Florida, 34471

  • St. Anthony Hospital

    Oklahoma City, Oklahoma, 73102

  • Phoenixville Hospital

    Phoenixville, Pennsylvania, 19460

  • First Health Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • University Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvania, 15213

  • UPMC Presbyterian Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

  • AtlantiCare Regional Medical Center

    Pomona, New Jersey, 08240

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Virginia Cardiovascular Specialists

    Richmond, Virginia, 23225

  • Piedmont Medical Center / Carolina Cardiology Associates

    Rock Hill, South Carolina, 29732

  • Harbin Clinic LLC

    Rome, Georgia, 30165

  • Michigan Cardio Vascular Institute at St. Mary's of MI

    Saginaw, Michigan, 48601

  • St. Johns Mercy Medical Center

    St Louis, Missouri, 63141

  • Tomball Regional Medical Center

    Tomball, Texas, 77375

  • Cardiovascular Associates, Ltd.

    Virginia Beach, Virginia, 23454

Other trials in United States

About this study

Official title: 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

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.

Keywords
Drug Eluting Stent, Percutaneous Coronary Intervention, Everolimus
Medical subject headings
Atherosclerosis, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00731237
Study groupRoleWhat they receive
1The 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 being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: acute

  2. Physician-determined procedure success

    Measured: acute

Secondary outcomes (12)

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

    Measured: acute

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

    Measured: acute

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

    Measured: acute

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

    Measured: acute

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

    Measured: acute

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

    Measured: acute

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

    Measured: acute

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

    Measured: acute

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

    Measured: acute

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

    Measured: acute

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

    Measured: acute

  12. Device Success

    Measured: acute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionMar 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,517 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00731237
Sponsor's protocol ID
08-382
Acronym
EXCEED
Status last verified
Oct 2009
First submitted
5 Aug 2008
Last updated
16 Oct 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atherosclerosis and Coronary Artery Disease, run by Abbott Medical Devices at 44 sites in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall physician-determined XIENCE V® EECSS acute performance and deliverability. (time frame: acute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00731237.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2009.

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