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Completed

NCT Number: NCT00731237

XIENCE V® 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

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

The Heart Center, PC, Huntsville, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Acronym: EXCEED

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 8, 2008
Registry last updated
Oct 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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