Coronary Artery Chronic Total OcclusionPhase 2FAST-CTOsNCT00886899
Facilitated Antegrade Steering Technique in Chronic Total Occlusions (FAST-CTOs)
A Phase 2 study testing Recanalization of a coronary chronic total occlusion in people with Coronary Artery Chronic Total Occlusion, run by BridgePoint Medical at 16 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Chronic Total Occlusion
- What is being tested?
- Recanalization of a coronary chronic total occlusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 16 sitesUnited States
- Study dates
- Mar 2009to Sep 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
St. Joseph Hospital
Bellingham, Washington, 98225
Cleveland Clinic
Cleveland, Ohio, 44195
Dallas VA Medical Center
Dallas, Texas, 75216
Mid America Heart Institute, St. Luke's Hospital
Kansas City, Missouri, 64111
Scripps Clinic
La Jolla, California, 92037
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Minneapolis Heart Institute, Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Intermountain Medical Center
Murray, Utah, 84157
Yale-New Haven Hospital
New Haven, Connecticut, 06520
Columbia University Medical Center
New York, New York, 10032
St. Luke's Medical Center
Phoenix, Arizona, 85006
Mayo Clinic - St. Mary's Hospital
Rochester, Minnesota, 55905
University of California Davis Heart & Vascular Center
Sacramento, California, 95817
Prairie Cardiovascular Consultants
Springfield, Illinois, 62701
Stanford University Hospital
Stanford, California, 94305
Torrance Memorial Medical Center
Torrance, California, 90505
About this study
Official title: 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.
- Conditions
- Coronary Artery Chronic Total Occlusion
- Being tested
- Recanalization of a coronary chronic total occlusion
- Keywords
- CTO, chronic total occlusion, CAD, coronary artery disease, interventional cardiology, revascularization, recanalization
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recanalization of a coronary chronic total occlusionDevice
Also called CrossBoss Catheter, Stingray Catheter, Stingray Guidewire
Crossing a CTO to allow definitive treatment via balloon angioplasty and/or stent placement
| Study group | Role | What they receive |
|---|---|---|
| BridgePoint Medical System | Experimental | Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire Receives: Device: Recanalization of a coronary chronic total occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 30 Days
Secondary outcomes (2)
Total Procedure Time
Minus any time to determine CTO was refractory to standard guidewire
Measured: Intraprocedural
Total Procedural Fluoroscopy Time
Minus any time to determine CTO was refractory to standard guidewire
Measured: Intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Chronic Total OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- BridgePoint Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Whitlow, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886899
- Sponsor's protocol ID
- 200-0002
- Acronym
- FAST-CTOs
- Status last verified
- Mar 2012
- First submitted
- 21 Apr 2009
- Last updated
- 20 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 22516395
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitated Antegrade Steering Technique in Chronic Total Occlusions
- ClinicalTrials.gov ID
- NCT00886899
- Acronym / sponsor ID
- FAST-CTOs / 200-0002
- Conditions
- Coronary Artery Chronic Total Occlusion
- Keywords
- CTO, chronic total occlusion, CAD, coronary artery disease, interventional cardiology, revascularization, recanalization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- BridgePoint MedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 23 Apr 2009 (estimated)
- Results
- Posted 13 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BridgePoint Medical System | Experimental | Device: Recanalization of a coronary chronic total occlusionAttempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recanalization of a coronary chronic total occlusionAlso: CrossBoss Catheter, Stingray Catheter, Stingray GuidewireCrossing a CTO to allow definitive treatment via balloon angioplasty and/or stent placement | Device | BridgePoint Medical System |
Primary outcome
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
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.
2 secondary outcomes
Total Procedure Time
Time frame: Intraprocedural
Total Procedural Fluoroscopy Time
Time frame: Intraprocedural
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22516395Whitlow 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Whitlow, MD principal investigator
The Cleveland Clinic
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recanalization of a coronary chronic total occlusion in people with Coronary Artery Chronic Total Occlusion, run by BridgePoint Medical at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (time frame: Intraprocedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00886899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2012.