The purpose of the CONSISTENT CTO study is to demonstrate that enhanced vascular healing with the Synergy stent should minimize the risk of late aneurysm formation and potential clinical complications but not at the cost of enhanced efficacy.
ClinicalTrials.gov ID: NCT02227771
Sponsor
Sponsored by Supported by
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Primary endpoints
- The primary stent endpoint is 12-month target vessel failure (TVF) rate [ Time Frame: 12 months ]
The primary stent endpoint is 12-month target vessel failure (TVF) rate, defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or cardiac death.
- The primary balloon endpoint is device procedural success [ Time Frame: 1 month ]
Successful delivery of the Emerge Coronary Dilatation catherter across the lesion and Successful inflation and removal of the Emerge Coronary Dilatation catherter with absences of clinically significant vessel perforation or flow limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) flow from baseline, clinically significant arrythmias requiring medical treatment or device intervention following dilatation with Emerge balloon and Achievment of final TIMLI 3 flow for the target lesion at the conclusion of the index procedure. The primary balloon endpoint will be evaluated in patients where an attempt to use an Emerge Coronary Dilatation catherter is made.
CERC Services
- Full Services
Countries
UK managed by CERC
Number of investigational sites
6
Number of patients
215
