CrossBoss and Stingray Catheter and Entera Guidewire Chronic Total Occlusion (CTO) Study

CrossBoss and Stingray Catheter and Entera Guidewire Chronic Total Occlusion (CTO) Study

This study is to determine if the BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire) can facilitate safe and effective placement of a guidewire in the true lumen of coronary vessels distal to a chronic total occlusion (CTO).

The hypothesis is that the BridgePoint Medical System can do this without an increase in major complications.

Inclusion Criteria:

• Suitable for coronary intervention
• de novo or restenotic CTO at least 3 months old, in proximal or mid coronary artery segment, 3.0-5.0 mm in diameter
• Mild/moderate proximal vessel tortuosity
• Mild/moderate lesion angulation
• Mild/moderate calcification
• Satisfactory distal vessel visualization
• Mild/moderate side branch interference
• 19 years old
• BMI<40
• LVEF>20%
• Signed informed consent

Exclusion Criteria:

• Extensive dissection from guidewire manipulation
• SVG or in-stent CTO
• Aorto-ostial CTO
• Unable to take aspirin, Clopidogrel, or Ticlopidine
• Thrombus/vessel filling defects
• Severe cerebrovascular disease/stroke within 1 month
• Intervention within 2 weeks
• Renal insufficiency
• GI bleeding
• Active infection
• Life expectancy <2 years
• Significant anemia
• Uncontrolled hypertension
• Severe electrolyte imbalance
• Anaphylaxis to contrast
• NYHA class IV
• Unstable angina requiring intervention
• MI within 2 weeks
• Uncontrolled diabetes
• Participating in another protocol
• Unwilling/unable to comply with protocol
• Angina/ischemia caused by target vessel