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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00801710

Enrollment

Registered

2008-12-03

Start date

2008-09-30

Completion date

2009-09-30

Last updated

2021-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Chronic Total Occlusion, Coronary Artery Disease

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.

Interventions

DEVICEBridgePoint 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
CTO Crossing Rate	Peri-procedural

Secondary

Measure	Time frame
Major Adverse Cardiac Events (MACE)	30 days
Perforation rate	Peri-procedural
Acute myocardial infarction (AMI)	Peri-procedural

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026