Philips IGTD Clinical Operations Manager: DEFINE GPS Study
Department
Biological Sciences
Advisor
Amy Dykstra
Document Type
Event
Version
Metadata Only
Abstract
Residual ischemia after angiographically successful percutaneous coronary intervention (PCI) is associated with worse outcomes in comparison to patients undergoing PCI that demonstrate a physiology measurement (fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR)) that is well above the ischemic cut-off point. The DEFINE GPS study (Distal Evaluation of Functional performance with Intravascular sensors to assess the Narrowing Effect: Guided Physiologic Stenting) was undertaken by Philips to demonstrate primarily that PCI guided by iFR co-registration using commercially available Philips pressure guidewires and SyncVision system is associated with superior clinical outcomes compared to PCI guided by angiography alone. This multi-center, prospective, randomized controlled study is employing an adaptive design for interim sample size re-estimation, with sample size ranging between 2151 – 3212 patients randomized at up to 125 sites globally. The study will be reviewed from the perspective of one of the Clinical Operations Managers tasked with operationalizing the protocol and managing the study. Site selection began in Q1 2020, with first subject enrolled June 2021, and 1000th subject enrolled October 2023. As of Q2 2024, 18 countries are actively enrolling with an interim analysis planned for summer 2024. The study is expected to conclude in Q2 2027.
Recommended Citation
Dierkhising, Christina and Dykstra, Amy, "Philips IGTD Clinical Operations Manager: DEFINE GPS Study" (2024). Science Symposium. 17.
https://spark.bethel.edu/science_symposium/spring2024/schedule2024/17
Philips IGTD Clinical Operations Manager: DEFINE GPS Study
Residual ischemia after angiographically successful percutaneous coronary intervention (PCI) is associated with worse outcomes in comparison to patients undergoing PCI that demonstrate a physiology measurement (fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR)) that is well above the ischemic cut-off point. The DEFINE GPS study (Distal Evaluation of Functional performance with Intravascular sensors to assess the Narrowing Effect: Guided Physiologic Stenting) was undertaken by Philips to demonstrate primarily that PCI guided by iFR co-registration using commercially available Philips pressure guidewires and SyncVision system is associated with superior clinical outcomes compared to PCI guided by angiography alone. This multi-center, prospective, randomized controlled study is employing an adaptive design for interim sample size re-estimation, with sample size ranging between 2151 – 3212 patients randomized at up to 125 sites globally. The study will be reviewed from the perspective of one of the Clinical Operations Managers tasked with operationalizing the protocol and managing the study. Site selection began in Q1 2020, with first subject enrolled June 2021, and 1000th subject enrolled October 2023. As of Q2 2024, 18 countries are actively enrolling with an interim analysis planned for summer 2024. The study is expected to conclude in Q2 2027.