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

Primary Purpose

Coronary Artery Disease, Coronary Artery Chronic Total Occlusion

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Main Taunus Hospital
  • Klinikum Darmstadt
  • CardioVascular Center Frankfurt, St. Katharinen Hospital
  • Universitäres Herz- und Gefässzentrum Hamburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BridgePoint Medial System

Arm Description

Outcomes

Primary Outcome Measures

CTO Crossing Rate

Secondary Outcome Measures

Major Adverse Cardiac Events (MACE)
Perforation rate
Acute myocardial infarction (AMI)

Full Information

First Posted
December 2, 2008
Last Updated
January 24, 2021
Sponsor
Boston Scientific Corporation
Collaborators
BridgePoint Medical
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1. Study Identification

Unique Protocol Identification Number
NCT00801710
Brief Title
CrossBoss and Stingray Catheter and Entera Guidewire Chronic Total Occlusion (CTO) Study
Official Title
CrossBoss and Stingray Catheter and Entera Guidewire Chronic Total Occlusion (CTO) Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
Collaborators
BridgePoint Medical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Artery Chronic Total Occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BridgePoint Medial System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)
Intervention Description
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
Primary Outcome Measure Information:
Title
CTO Crossing Rate
Time Frame
Peri-procedural
Secondary Outcome Measure Information:
Title
Major Adverse Cardiac Events (MACE)
Time Frame
30 days
Title
Perforation rate
Time Frame
Peri-procedural
Title
Acute myocardial infarction (AMI)
Time Frame
Peri-procedural

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horst Sievert, MD
Organizational Affiliation
CardioVascular Center Frankfurt, St. Katharinen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Main Taunus Hospital
City
Bad Soden
Country
Germany
Facility Name
Klinikum Darmstadt
City
Darmstadt
Country
Germany
Facility Name
CardioVascular Center Frankfurt, St. Katharinen Hospital
City
Frankfurt
Country
Germany
Facility Name
Universitäres Herz- und Gefässzentrum Hamburg
City
Hamburg
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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