Ignite Creation Date:
2024-05-05 @ 9:40 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00937573
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2009-07-10
Brief Title:
Xience V at Wake Forest University Baptist Medical Center WFUBMC
Sponsor:
Wake Forest University
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Xience V at WFUBMC Real World Outcomes Using Second Generation DES
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1200 patients and a DES cohort of 1200 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
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 1200 patients and a DES cohort of 1200 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None