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

This study has been completed.
Sponsor:
Information provided by:
BridgePoint Medical
ClinicalTrials.gov Identifier:
NCT00801710
First received: December 2, 2008
Last updated: December 2, 2009
Last verified: December 2009
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CrossBoss and Stingray Catheter and Entera Guidewire Chronic Total Occlusion (CTO) Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by BridgePoint Medical:

Primary Outcome Measures:
  • CTO Crossing Rate [ Time Frame: Peri-procedural ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: John Schultz, Vice President, Clinical Affairs, BridgePoint Medical
ClinicalTrials.gov Identifier: NCT00801710     History of Changes
Other Study ID Numbers: 200-0001
Study First Received: December 2, 2008
Last Updated: December 2, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 23, 2013