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Xience V at Wake Forest University Baptist Medical Center (WFUBMC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00937573
First Posted: July 13, 2009
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abbott
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )
  Purpose

The effectiveness, safety, and deliverability of second generation drug eluting stents (DES), including Xience V, will need to be examined in real world patients to provide the same level of evidence base and comfort that has accompanied the use of the first generation devices. Randomized clinical trials provide the fairest evaluation of outcomes by controlling for confounding patient and procedural characteristics; however, randomized clinical trials also exclude the very high risk patients that account for upwards of 80% of real world patient populations such as those at Wake Forest University Baptist Medical Center (WFUBMC).

Clinical follow-up data including non-fatal MI, all cause mortality and stent thrombosis, as well as medications compliance, of patients undergoing stent therapy including Xience V in a real world patient population will be collected at WFUBMC. Existing data for several control groups will be used to compare outcomes with Xience V including a consecutively treated bare metal stent (BMS) cohort of 1,200 patients, and a DES cohort of 1,200 patients (900 sirolimus-eluting and 300 paclitaxel-eluting) treated between April 2004 and April 2005. Patients undergoing stent therapy in the year prior to use of Xience V, and contemporaneous patients receiving non-Xience V stent therapy during Xience V use will serve as additional controls. All patient data will be de-identified using unique blinded identification codes after data collection is completed.

The null hypothesis of this study states that safety outcomes (stent thrombosis, non-fatal MI, death) with Xience V will be equivalent to historical and contemporaneous controls; effectiveness outcomes (target lesion and target vessel revascularization) with Xience V will be superior to historical and contemporaneous BMS controls, and equivalent to historical and contemporaneous DES controls; and the need for crossover to another stent type will be equal to that observed with historical DES controls. Outcomes will be reported using contemporary measures of clinical outcomes and analyzed using Cox proportional hazards survival analysis methodology. These data should provide important information on the clinical effectiveness and safety of Xience V in routine practice.


Condition
Percutaneous Coronary Intervention Stents

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Xience V at WFUBMC: Real World Outcomes Using Second Generation DES

Further study details as provided by Wake Forest University Health Sciences ( Wake Forest University ):

Primary Outcome Measures:
  • Composite of non-fatal myocardial infarction, death, or stent thrombosis [ Time Frame: Annual landmark ]

Secondary Outcome Measures:
  • Target lesion/vessel revascularization [ Time Frame: Annual landmark ]

Enrollment: 59
Study Start Date: July 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Xience V
Percutaneous coronary intervention with Xience V stent placement
Historical BMS
Percutaneous coronary intervention with bare metal stent placement prior to availability of Cypher, Taxus, or Xience V drug eluting stents at WFUBMC
Historical DES
Percutaneous coronary intervention with drug eluting stent placement prior to availability of Xience V drug eluting stents at WFUBMC
Contemporary BMS
Percutaneous coronary intervention with bare metal stent placement after Xience V drug eluting stents were available for use at WFUBMC
Contemporary DES
Percutaneous coronary intervention with Cypher or Taxus drug eluting stent placement after Xience V drug eluting stents were available for use at WFUBMC

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with coronary artery disease seen at WFUBMC cardiac catheterization laboratory who received percutaneous coronary intervention with placement of one or more stents
Criteria

Inclusion Criteria:

  • percutaneous coronary intervention with stenting

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937573


Locations
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27517
Sponsors and Collaborators
Wake Forest University
Abbott
Investigators
Principal Investigator: Robert J Applegate, MD Wake Forest University
  More Information

Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00937573     History of Changes
Other Study ID Numbers: ACS-6814
First Submitted: July 10, 2009
First Posted: July 13, 2009
Last Update Posted: November 6, 2017
Last Verified: December 2014

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
stents
mortality
revascularization
stent thrombosis
Drug-Eluting Stents