FAST-CTOs Study
Enrollment in FAST-CTOs - Facilitated Antegrade Steering Technique in Chronic Total Occlusions - initiated in Europe and planned for the United States
Up to 300 patients (150 US; 150 EU) presenting with a CTO refractory to conventional guidewire use - defined by one of the following:
- A minimum of 10 minutes of fluoroscopy time with the cardiologist’s choice of guidewire(s) unable to cross
- Previous crossing attempt
- Or if best effort attempts result in the conventional guidewire antegrade advancement into the subintimal plane
Technical Success Defined As:
The ability of the CrossBoss™ CTO Catheter, Stingray™ CTO Orienting Balloon Catheter and/or Stingray™ Re-Entry Guidewire to successfully facilitate placement of a guidewire beyond a CTO in the vessel true lumen in cases that were otherwise refractory to treatment with a conventional guidewire.
Safety Endpoint: 30-Day MACE Rates
For more info on Clinical Study Design
Procedure Sequence
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