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

This study has been completed.
Sponsor:
Information provided by:
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00731237
First received: August 5, 2008
Last updated: October 15, 2009
Last verified: October 2009
History of Changes
  Purpose

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


Condition
Atherosclerosis
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Overall physician-determined XIENCE V® EECSS acute performance and deliverability. [ Time Frame: acute ] [ Designated as safety issue: No ]
  • Physician-determined procedure success [ Time Frame: acute ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Individual component of adjunctive devices and drugs used during procedure. Number and type of guide wires [ Time Frame: acute ] [ Designated as safety issue: No ]
  • Individual component of adjunctive devices and drugs used during procedure. Number and type of guiding catheters [ Time Frame: acute ] [ Designated as safety issue: No ]
  • Individual component of adjunctive devices and drugs used during procedure. Number and type of balloon dilation catheters [ Time Frame: acute ] [ Designated as safety issue: No ]
  • Individual component of adjunctive devices and drugs used during procedure: Balloon pressures (pre-dilation/post-dilation pressures) [ Time Frame: acute ] [ Designated as safety issue: No ]
  • Individual component of adjunctive devices and drugs used during procedure: Number of stents [ Time Frame: acute ] [ Designated as safety issue: No ]
  • Individual component of adjunctive devices and drugs used during procedure: Amount of radiographic contrast [ Time Frame: acute ] [ Designated as safety issue: No ]
  • Individual component of adjunctive devices and drugs used during procedure: Fluoroscopy time [ Time Frame: acute ] [ Designated as safety issue: No ]
  • Individual component of adjunctive devices and drugs used during procedure: Duration of PCI procedure [ Time Frame: acute ] [ Designated as safety issue: No ]
  • Individual component of adjunctive devices and drugs used during procedure: IVUS use [ Time Frame: acute ] [ Designated as safety issue: No ]
  • Individual component of adjunctive devices and drugs used during procedure: Thienopyridine loading dose (prior to, during or after procedure) [ Time Frame: acute ] [ Designated as safety issue: No ]
  • Individual component of adjunctive devices and drugs used during procedure: Aspirin loading dose (prior to, during or after procedure) [ Time Frame: acute ] [ Designated as safety issue: No ]
  • Device Success [ Time Frame: acute ] [ Designated as safety issue: No ]

Enrollment: 2517
Study Start Date: October 2008
Study Completion Date: October 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/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.

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.

  Eligibility

Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731237

  Show 44 Study Locations
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: John McPherson, MD Vanderbuilt University
  More Information

No publications provided

Responsible Party: Matt Kiely, Manager Medical Information, Abbott Vascular
ClinicalTrials.gov Identifier: NCT00731237     History of Changes
Other Study ID Numbers: 08-382
Study First Received: August 5, 2008
Last Updated: October 15, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Abbott Vascular:
Drug Eluting Stent
Percutaneous Coronary Intervention
Everolimus

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Cardiovascular Diseases
Heart Diseases
Everolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013