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OpenTrials
Completed

NCT Number: NCT00801710

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

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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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Chronic Total Occlusion Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Main Taunus Hospital, Bad Soden, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. CTO Crossing Rate

    Time frame: Peri-procedural

Secondary outcomes

  1. Major Adverse Cardiac Events (MACE)

    Time frame: 30 days

  2. Perforation rate

    Time frame: Peri-procedural

  3. Acute myocardial infarction (AMI)

    Time frame: Peri-procedural

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Collaborators

  • BridgePoint Medical

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 3, 2008
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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