First in Man
Methods
29 patients with de novo Chronic Total Occlusions in native coronary arteries who had been scheduled for bypass surgery or were being managed medically were treated at 3 centers in Santiago and Viña del Mar, Chile.
The primary crossing method for PCI included one or all components:
- The CrossBoss™ CTO Catheter
- The Stingray™ CTO Orienting Balloon Catheter
- The Stingray™ CTO Re-Entry Guidewire
Endpoints:
- Technical Success (ability to place a guidewire into the true lumen distal to the CTO)
- Angiographic Success (<30% residual stenosis with TIMI III antegrade flow)
- 30-day Clinical Success (angiographic success and freedom from major adverse cardiac events [MACE])
- In-Hospital MACE (death, periprocedural myocardial infarction, major perforation)
- 30-day MACE (death, myocardial infarction)
Results
Twenty-nine patients (75% male, 52% diabetic) with 29 CTOs were treated with a combination of the CrossBoss and Stingray devices. The lesion morphology included an average length of 23.5 mm in the following vessels: 31% RCA, 41% LAD and 28% LCX. Technical success and angiographic success were obtained in 25/29 (86.2%) patients. There were no in-hospital MACE. Of the 13 patients followed for 30 days to date, no adverse events have been reported.
Conclusions
The CrossBoss CTO Catheter, The Stingray CTO Orienting Balloon Catheter and The Stingray CTO Re-Entry Guidewire represent a feasible approach in crossing chronic total coronary occlusions. Additional clinical studies are warranted.