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

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Artery Disease, Coronary Artery Chronic Total Occlusion

Intervention / Treatment
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* Device: BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BridgePoint Medial System<br> | Device: BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)<br>* Revascularization of coronary artery chronic total occlusion. Use of the BridgePoint Medical System to cross coronary CTOs prior to definitive revascularization treatment via angioplasty and/or stent implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CTO Crossing Rate |  | Peri-procedural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events (MACE) |  | 30 days | 
| Perforation rate |  | Peri-procedural | 
| Acute myocardial infarction (AMI) |  | Peri-procedural |