Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00937573 · ClinicalTrials.gov registry record
Xience V at Wake Forest University Baptist Medical Center (WFUBMC)
A clinical trial, sponsored by Wake Forest University.
- Completed
- Registry status
- 59
- Enrollment target
NCT00937573 is a clinical trial that has completed, run by Wake Forest University. The registered enrollment target is 59 participants.
The verdict
NCT00937573 has completed, sponsored by Wake Forest University.
- COMPLETED
- Registry status
- 59 participants
- Enrollment target
Study 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. O
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2009-07 |
| Est. Completion | 2013-08 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00937573
The ClinicalTrials.gov registry entry for NCT00937573 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University, which has 100 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00937573 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00937573 about?
NCT00937573 is a clinical study titled "Xience V at Wake Forest University Baptist Medical Center (WFUBMC)". 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 t...
What is the current status of trial NCT00937573?
This trial is currently completed. The enrollment target is 59 participants. The study started on 2009-07. Estimated completion is 2013-08.
Who is sponsoring clinical trial NCT00937573?
This trial is sponsored by Wake Forest University, which has 100 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.