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

Boston Scientific

Status: Completed

Conditions: Coronary Artery Disease; Coronary Artery Chronic Total Occlusion

Treatments: Device: BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00801710

200-0001

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

BridgePoint Medial System

Experimental group

Treatment:

Device: BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)