Status:
COMPLETED
CrossBoss and Stingray Catheter and Entera Guidewire Chronic Total Occlusion (CTO) Study
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
BridgePoint Medical
Conditions:
Coronary Artery Disease
Coronary Artery Chronic Total Occlusion
Eligibility:
All Genders
19+ years
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00801710
Start Date
September 1 2008
End Date
September 1 2009
Last Update
January 26 2021
Active Locations (4)
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1
Main Taunus Hospital
Bad Soden, Germany
2
Klinikum Darmstadt
Darmstadt, Germany
3
CardioVascular Center Frankfurt, St. Katharinen Hospital
Frankfurt, Germany
4
Universitäres Herz- und Gefässzentrum Hamburg
Hamburg, Germany