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

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ClinicalTrials.gov Identifier: NCT00801710
Recruitment Status : Completed
First Posted : December 3, 2008
Last Update Posted : December 4, 2009
Sponsor:
Information provided by:
BridgePoint Medical

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Artery Chronic Total Occlusion Device: BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CrossBoss and Stingray Catheter and Entera Guidewire Chronic Total Occlusion (CTO) Study
Study Start Date : September 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: BridgePoint Medial System Device: BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)

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




Primary Outcome Measures :
  1. CTO Crossing Rate [ Time Frame: Peri-procedural ]

Secondary Outcome Measures :
  1. Major Adverse Cardiac Events (MACE) [ Time Frame: 30 days ]
  2. Perforation rate [ Time Frame: Peri-procedural ]
  3. Acute myocardial infarction (AMI) [ Time Frame: Peri-procedural ]


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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00801710


Locations
Germany
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
Sponsors and Collaborators
BridgePoint Medical
Investigators
Principal Investigator: Horst Sievert, MD CardioVascular Center Frankfurt, St. Katharinen Hospital

Responsible Party: John Schultz, Vice President, Clinical Affairs, BridgePoint Medical
ClinicalTrials.gov Identifier: NCT00801710     History of Changes
Other Study ID Numbers: 200-0001
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: December 4, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases