We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00801710
First Posted: December 3, 2008
Last Update Posted: December 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
BridgePoint Medical
  Purpose

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 Intervention
Coronary Artery Disease Coronary Artery Chronic Total Occlusion Device: BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)

Study Type: Interventional
Study Design: 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

Further study details as provided by BridgePoint Medical:

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

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

Enrollment: 42
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: John Schultz, Vice President, Clinical Affairs, BridgePoint Medical
ClinicalTrials.gov Identifier: NCT00801710     History of Changes
Other Study ID Numbers: 200-0001
First Submitted: December 2, 2008
First Posted: December 3, 2008
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