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Completed

NCT Number: NCT00886899

Facilitated Antegrade Steering Technique in Chronic Total Occlusions (FAST-CTOs)

Prospective, non-randomized, multicenter study in subjects with coronary artery chronic total occlusions (CTOs). Published results of safety and effectiveness of conventional techniques will be used for comparison. Enrollment of up to 149 subjects with a CTO refractory to currently marketed guidewire use and meeting all inclusion/exclusion criteria at up to 15 US clinical sites. Hypothesis is that the BridgePoint Medical System is safe and effective in treating coronary CTOs compared to CTO literature.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Luke's Medical Center, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • suitable candidate for non-emergent, coronary angioplasty
  • documented coronary CTO lesion with the following characteristics: a) Thrombolysis in Myocardial Infarction (TIMI) 0 flow for at least 90 days; b) satisfactory distal vessel visualization; and c) refractory to currently marketed guidewire crossing via 1 of the following: 1. previous failed attempt to cross CTO within the past 12 months; or 2. unsuccessful CTO crossing w/ guidewire (10-15 min fluoro time); or 3. attempt to cross CTO w/ guidewire results in subintimal guidewire
  • angina or ischemia caused by the occluded artery
  • at least 18 years of age
  • Body Mass Index (BMI) < 40
  • left ventricle ejection fraction > 20%
  • sign the Informed Consent Form

Exclusion criteria

  • saphenous vein graft (SVG) CTO or an in-stent CTO
  • aorto-ostial CTO location. (Ostial bifurcation origins may be considered)
  • intolerance to aspirin or a neutropenic response to Ticlopidine/Clopidogrel
  • appearance of thrombus or intraluminal filling defects
  • severe cerebrovascular disease (history of stroke or TIA within 1 month)
  • cardiac intervention within two weeks of the procedure
  • renal insufficiency (serum creatinine of > 2.3 mg/dl)
  • active gastrointestinal bleeding
  • active infection or fever that may be due to infection
  • life expectancy < 2 years due to other illnesses
  • significant anemia (hemoglobin < 8.0 mg / dl)
  • severe uncontrolled systemic hypertension
  • severe electrolyte imbalance
  • anaphylaxis to angiographic contrast media unless appropriately medicated
  • congestive heart failure [New York Heart Association (NYHA) Class IV]
  • unstable angina requiring emergent percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
  • recent myocardial infarction (MI)(within the past two weeks)
  • uncontrolled diabetes
  • participation in another investigational protocol
  • unwillingness or inability to comply with any protocol requirements
  • pregnant or nursing
  • extensive dissection from refractory guidewire use
  • crossing CTO (true lumen) w/ guidewire within 10-15 min of fluoro time

Treatment and study plan

Recanalization of a coronary chronic total occlusion

Device

Crossing a CTO to allow definitive treatment via balloon angioplasty and/or stent placement

Other names: CrossBoss Catheter, Stingray Catheter, Stingray Guidewire

Primary outcomes

  1. Technical Success

    Time frame: Intraprocedural

    Defined as the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a chronic total occlusion (CTO) in the true vessel lumen in cases that were otherwise refractory to treatment with a currently marketed guidewire

  2. 30-day Major Adverse Cardiac Event (MACE) Rate

    Time frame: 30 Days

    Defined as cardiac death, Q-wave and non-Q-wave [total creatinine kinase (CK) >2x upper limit of normal with a positive myocardial band (MB) fraction] myocardial infarction (MI), target lesion revascularization (TLR), and emergency bypass surgery.

Secondary outcomes

  1. Total Procedure Time

    Time frame: Intraprocedural

    Minus any time to determine CTO was refractory to standard guidewire

  2. Total Procedural Fluoroscopy Time

    Time frame: Intraprocedural

    Minus any time to determine CTO was refractory to standard guidewire

Sponsors and collaborators

Lead sponsor

BridgePoint Medical

Industry

Registry information

Official study title

Facilitated Antegrade Steering Technique in Chronic Total Occlusions

Acronym: FAST-CTOs

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 23, 2009
Registry last updated
Mar 20, 2012

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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