CrossBoss and Stingray Catheter and Entera Guidewire Chronic Total Occlusion (CTO) Study
1 other identifier
interventional
42
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Sep 2008
Shorter than P25 for not_applicable coronary-artery-disease
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedJanuary 26, 2021
January 1, 2021
9 months
December 2, 2008
January 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
CTO Crossing Rate
Peri-procedural
Secondary Outcomes (3)
Major Adverse Cardiac Events (MACE)
30 days
Perforation rate
Peri-procedural
Acute myocardial infarction (AMI)
Peri-procedural
Study Arms (1)
BridgePoint Medial System
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
- years old
- BMI\<40
- LVEF\>20%
- Signed informed consent
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Scientific Corporationlead
- BridgePoint Medicalcollaborator
Study Sites (4)
Main Taunus Hospital
Bad Soden, Germany
Klinikum Darmstadt
Darmstadt, Germany
CardioVascular Center Frankfurt, St. Katharinen Hospital
Frankfurt, Germany
Universitäres Herz- und Gefässzentrum Hamburg
Hamburg, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Horst Sievert, MD
CardioVascular Center Frankfurt, St. Katharinen Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2008
First Posted
December 3, 2008
Study Start
September 1, 2008
Primary Completion
June 1, 2009
Study Completion
September 1, 2009
Last Updated
January 26, 2021
Record last verified: 2021-01