CrossBoss and Stingray Catheter and Entera Guidewire Chronic Total Occlusion (CTO) Study - Full Text View

Sponsored by:	BridgePoint Medical
Information provided by:	BridgePoint Medical
ClinicalTrials.gov Identifier:	NCT00801710

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)

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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 ] [ 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:	20
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
BridgePoint Medial System: Experimental	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
CardioVascular Center Frankfurt, St. Katharinen Hospital
Frankfurt, Germany
Klinikum Darmstadt
Darmstadt, Germany
Universitäres Herz- und Gefässzentrum Hamburg
Hamburg, Germany
Main Taunus Hospital
Bad Soden, Germany

Sponsors and Collaborators

BridgePoint Medical

Investigators

Principal Investigator:

Horst Sievert, MD

CardioVascular Center Frankfurt, St. Katharinen Hospital

More Information

Responsible Party:	BridgePoint Medical ( John Schultz, Vice President, Clinical Affairs )
Study ID Numbers:	200-0001
Study First Received:	December 2, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00801710
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009