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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BridgePoint Medical
ClinicalTrials.gov Identifier:
NCT00886899
First received: April 21, 2009
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Coronary Artery Chronic Total Occlusion
Device: Recanalization of a coronary chronic total occlusion
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Facilitated Antegrade Steering Technique in Chronic Total Occlusions

Further study details as provided by BridgePoint Medical:

Primary Outcome Measures:
  • Technical Success [ Time Frame: Intraprocedural ] [ Designated as safety issue: No ]
    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

  • 30-day Major Adverse Cardiac Event (MACE) Rate [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Total Procedure Time [ Time Frame: Intraprocedural ] [ Designated as safety issue: No ]
    Minus any time to determine CTO was refractory to standard guidewire

  • Total Procedural Fluoroscopy Time [ Time Frame: Intraprocedural ] [ Designated as safety issue: No ]
    Minus any time to determine CTO was refractory to standard guidewire


Enrollment: 147
Study Start Date: March 2009
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886899

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

No publications provided by BridgePoint Medical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: BridgePoint Medical
ClinicalTrials.gov Identifier: NCT00886899     History of Changes
Other Study ID Numbers: 200-0002
Study First Received: April 21, 2009
Results First Received: February 21, 2012
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by BridgePoint Medical:
CTO
chronic total occlusion
CAD
coronary artery disease
interventional cardiology
revascularization
recanalization

ClinicalTrials.gov processed this record on October 20, 2014