Chronic Total OcclusionPhase 3PFAST-CTOsNCT01246505
Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions
A Phase 3 study testing CTO Crossing and Percutaneous transluminal angioplasty in people with Chronic Total Occlusion, run by BridgePoint Medical at 10 sites in United States.
Trial summary
Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the lower extremities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion
- What is being tested?
- CTO Crossing and Percutaneous transluminal angioplasty
- Type of treatment
- Medical device
- How many people
- 105 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2011to Jan 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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, peripheral angioplasty
- documented de-novo or restenotic peripheral CTO lesion with TIMI 0 flow for at least 90 days and satisfactory distal vessel visualization (collateral supply)
- limb ischemia or claudication, Rutherford class I-III (grade 1-5) caused by the occluded artery
Who cannot join
- intolerance to aspirin or a neutropenic response to Ticlopidine or Clopidogrel
- appearance of thrombus or intraluminal filling defects
- peripheral intervention in the target limb within two weeks of the procedure
- renal insufficiency (serum creatinine of > 2.3 mg/dl)
- contraindication to a peripheral artery intervention
- participation in another investigational protocol
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Emory University Medical Center
Atlanta, Georgia
St. Joseph Hospital
Bellingham, Washington
Dallas VA Medical Center
Dallas, Texas
University of Colorado Denver
Denver, Colorado
University of Southern California Medical Center
Los Angeles, California
Columbia University Medical Center
New York, New York
St. Luke's Medical Center
Phoenix, Arizona
Wake Heart Center
Raleigh, North Carolina
Prairie Cardiovascular Consultants
Springfield, Illinois, 62701
Torrance Memorial Medical Center
Torrance, California
About this study
Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the lower extremities.
- Conditions
- Chronic Total Occlusion
- Being tested
- CTO Crossing and Percutaneous transluminal angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTO Crossing and Percutaneous transluminal angioplastyDevice
Crossing of the CTO with the BridgePoint Medical System and subsequent treatment of the CTO via PTA (specific devices to be used for PTA at investigators' discretion)
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Patients with a Major Adverse Events (MAE)
MAE is defined as death, major unplanned amputation, perforation requiring intervention, or target lesion revascularization due to complication.
Measured: 30 Day
Incidence of Intraprocedural Technical Success
Technical success is defined as the placement of a guidewire in the true lumen distal to the CTO
Measured: Intraprocedural (<24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- BridgePoint Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William A Gray, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246505
- Sponsor's protocol ID
- 200-0012
- Acronym
- PFAST-CTOs
- Status last verified
- Jul 2012
- First submitted
- 19 Nov 2010
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions
- ClinicalTrials.gov ID
- NCT01246505
- Acronym / sponsor ID
- PFAST-CTOs / 200-0012
- Conditions
- Chronic Total Occlusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- BridgePoint MedicalIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the lower extremities.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- suitable candidate for non-emergent, peripheral angioplasty
- documented de-novo or restenotic peripheral CTO lesion with TIMI 0 flow for at least 90 days and satisfactory distal vessel visualization (collateral supply)
- limb ischemia or claudication, Rutherford class I-III (grade 1-5) caused by the occluded artery
Key exclusion criteria (6 listed)
- intolerance to aspirin or a neutropenic response to Ticlopidine or Clopidogrel
- appearance of thrombus or intraluminal filling defects
- peripheral intervention in the target limb within two weeks of the procedure
- renal insufficiency (serum creatinine of > 2.3 mg/dl)
- contraindication to a peripheral artery intervention
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 |
|---|---|---|
| CTO Crossing and Percutaneous transluminal angioplastyCrossing of the CTO with the BridgePoint Medical System and subsequent treatment of the CTO via PTA (specific devices to be used for PTA at investigators' discretion) | Device | – |
Primary outcome
Incidence of Patients with a Major Adverse Events (MAE)
Time frame: 30 Day
MAE is defined as death, major unplanned amputation, perforation requiring intervention, or target lesion revascularization due to complication.
Incidence of Intraprocedural Technical Success
Time frame: Intraprocedural (<24 hours)
Technical success is defined as the placement of a guidewire in the true lumen distal to the CTO
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
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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.
William A Gray, MD principal investigator
Columbia University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CTO Crossing and Percutaneous transluminal angioplasty in people with Chronic Total Occlusion, run by BridgePoint Medical at 10 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 3 inclusion and 6 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 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Patients with a Major Adverse Events (MAE) (time frame: 30 Day). 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?
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 12 Jul 2012.