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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801710
• Other study ID #: 200-0001
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: January 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Chronic Total Occlusion
• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	BridgePoint Medical

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CTO Crossing Rate		Peri-procedural
Secondary	Major Adverse Cardiac Events (MACE)		30 days
Secondary	Perforation rate		Peri-procedural
Secondary	Acute myocardial infarction (AMI)		Peri-procedural