- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00801710
CrossBoss and Stingray Catheter and Entera Guidewire Chronic Total Occlusion (CTO) Study
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bad Soden, Germany
- Main Taunus Hospital
-
Darmstadt, Germany
- Klinikum Darmstadt
-
Frankfurt, Germany
- CardioVascular Center Frankfurt, St. Katharinen Hospital
-
Hamburg, Germany
- Universitäres Herz- und Gefäßzentrum Hamburg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BridgePoint Medial System
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CTO Crossing Rate
Time Frame: Peri-procedural
|
Peri-procedural
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Major Adverse Cardiac Events (MACE)
Time Frame: 30 days
|
30 days
|
Perforation rate
Time Frame: Peri-procedural
|
Peri-procedural
|
Acute myocardial infarction (AMI)
Time Frame: Peri-procedural
|
Peri-procedural
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Horst Sievert, MD, CardioVascular Center Frankfurt, St. Katharinen Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200-0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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