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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Wake Forest School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00937573
First received: July 10, 2009
Last updated: July 13, 2010
Last verified: July 2010
  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 School of Medicine:

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

Secondary Outcome Measures:
  • Target lesion/vessel revascularization [ Time Frame: Annual landmark ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: July 2009
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937573

Contacts
Contact: Robert J Applegate, MD (336) 716-3272 bapplega@wfubmc.edu
Contact: Matthew T Sacrinty, MPH (336) 713-2339 msacrint@wfubmc.edu

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

No publications provided

Responsible Party: Robert J. Applegate, MD, Wake Forest University
ClinicalTrials.gov Identifier: NCT00937573     History of Changes
Other Study ID Numbers: ACS-6814
Study First Received: July 10, 2009
Last Updated: July 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
stents
mortality
revascularization
stent thrombosis
Drug-Eluting Stents

ClinicalTrials.gov processed this record on April 17, 2014