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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov processed this record on September 18, 2014