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

NCT00937573 | Completed

• 1 other identifier: ACS-6814
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Percutaneous Coronary Intervention; Stents

Keywords

stents; mortality; revascularization; stent thrombosis; Drug-Eluting Stents

Outcome Measures

Primary Outcomes (1)

• Composite of non-fatal myocardial infarction, death, or stent thrombosis

  Annual landmark

Secondary Outcomes (1)

• Target lesion/vessel revascularization

  Annual landmark

Study Arms (5)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• percutaneous coronary intervention with stenting

You may not qualify if:

• none

Sponsors & Collaborators

• Wake Forest University: lead
• Abbott: collaborator

Study Sites (1)

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27517, United States

Location

Study Officials

• Robert J Applegate, MD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2009
• First Posted: July 13, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 6, 2017

Record last verified: 2014-12

Locations

US (1)