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

August 5, 2008
October 15, 2009
October 2008
March 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Total procedural costs based on resource utilization of disposable cath lab resources based on representative unit costs at the time of completion of the study. [ Time Frame: acute ] [ Designated as safety issue: No ]
  • Physician-determined procedure success [ Time Frame: acute ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00731237 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Individual component comparisons of adjunctive devices and drugs used during procedure. [ Time Frame: acute ] [ Designated as safety issue: No ]
  • Angiographic core lab qualitative and quantitative vessel and lesion measurements on all procedures, including core lab determination of procedure success. [ Time Frame: 14, 30, 180 days and 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: No ]
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XIENCE V® EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery
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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

  • Atherosclerosis
  • Coronary Artery Disease
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2517
October 2009
March 2009   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00731237
08-382
No
Matt Kiely, Manager Medical Information, Abbott Vascular
Abbott Vascular
Not Provided
Principal Investigator: John McPherson, MD Vanderbuilt University
Abbott Vascular
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP