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

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Coronary Artery Chronic Total Occlusion
• Interventions: Device: BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)

• Registration Number: NCT00801710
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-02
• Study First Posted: 2008-12-03
• Primary Completion: 2009-06
• Study Completion: 2009-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-24
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BridgePoint Medial System	BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)	-

Primary Outcome Measures

Name	Time	Method
CTO Crossing Rate	Peri-procedural

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events (MACE)	30 days
Acute myocardial infarction (AMI)	Peri-procedural
Perforation rate	Peri-procedural

Trial Locations

Locations (4)

CardioVascular Center Frankfurt, St. Katharinen Hospital; 🇩🇪 Frankfurt, Germany

Universitäres Herz- und Gefässzentrum Hamburg; 🇩🇪 Hamburg, Germany

Main Taunus Hospital; 🇩🇪 Bad Soden, Germany

Klinikum Darmstadt; 🇩🇪 Darmstadt, Germany