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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease Coronary Artery Chronic Total Occlusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BridgePoint Medial System

Group Type EXPERIMENTAL

BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No