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

Facilitated Antegrade Steering Technique in Chronic Total Occlusions

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Chronic Total Occlusion
• Intervention / Treatment: Device: Recanalization of a coronary chronic total occlusion

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • St. Luke's Medical Center
  • California
    • La Jolla, California, United States, 92037
      • Scripps Clinic
    • Sacramento, California, United States, 95817
      • University of California Davis Heart & Vascular Center
    • Stanford, California, United States, 94305
      • Stanford University Hospital
    • Torrance, California, United States, 90505
      • Torrance Memorial Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale-New Haven Hospital
  • Illinois
    • Springfield, Illinois, United States, 62701
      • Prairie Cardiovascular Consultants
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute, Abbott Northwestern Hospital
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - St. Mary's Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Mid America Heart Institute, St. Luke's Hospital
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Texas
    • Dallas, Texas, United States, 75216
      • Dallas VA Medical Center
  • Utah
    • Murray, Utah, United States, 84157
      • Intermountain Medical Center
  • Washington
    • Bellingham, Washington, United States, 98225
      • St. Joseph Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BridgePoint Medical System; Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire	Device: Recanalization of a coronary chronic total occlusion; Crossing a CTO to allow definitive treatment via balloon angioplasty and/or stent placement; Other Names: CrossBoss Catheter; Stingray Catheter; Stingray Guidewire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	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	Intraprocedural
30-day Major Adverse Cardiac Event (MACE) Rate	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.	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Procedure Time	Minus any time to determine CTO was refractory to standard guidewire	Intraprocedural
Total Procedural Fluoroscopy Time	Minus any time to determine CTO was refractory to standard guidewire	Intraprocedural

Collaborators and Investigators

• Sponsor: BridgePoint Medical
• Investigators: Principal Investigator: Patrick Whitlow, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• Whitlow PL, Burke MN, Lombardi WL, Wyman RM, Moses JW, Brilakis ES, Heuser RR, Rihal CS, Lansky AJ, Thompson CA; FAST-CTOs Trial Investigators. Use of a novel crossing and re-entry system in coronary chronic total occlusions that have failed standard crossing techniques: results of the FAST-CTOs (Facilitated Antegrade Steering Technique in Chronic Total Occlusions) trial. JACC Cardiovasc Interv. 2012 Apr;5(4):393-401. doi: 10.1016/j.jcin.2012.01.014.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: April 21, 2009
• First Submitted That Met QC Criteria: April 21, 2009
• First Posted (Estimate): April 23, 2009

Study Record Updates

• Last Update Posted (Estimate): March 20, 2012
• Last Update Submitted That Met QC Criteria: March 15, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: coronary artery disease; chronic total occlusion; revascularization; CAD; recanalization; CTO; interventional cardiology
• Other Study ID Numbers: 200-0002