Peripheral Vascular DiseasesPhase 4PROOFNCT00504088
Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
A Phase 4 study testing Bypass and Silverhawk Plaque Excision in people with Peripheral Vascular Diseases, run by FoxHollow Technologies at 31 sites in United States.
Trial summary
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- Bypass and Silverhawk Plaque Excision
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 31 sitesUnited States
- Study dates
- Oct 2006to not given
- Phase
- Phase 4
- 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
- Ischemic rest pain for more than 2 weeks or ulceration or gangrene of the foot or toes (Rutherford Becker Category 4, 5 or 6)
- Willing and able, as evaluated by the PI, to provide Informed Consent
- Willing to undergo up to 5 years of clinical follow up visits as scheduled
- Angiographic pattern of infrainguinal disease that can be reasonably managed either by surgery or plaque excision in the first instance
- Reconstitution of at least one patent target tibial segment below the knee which provides run-off to the foot
- The patient must be >18 years of age
Show all 9Show fewer
- Target lesion(s) is located at or below the level of the superficial femoral artery
- Target lesion(s) is >50% stenosed by quantitative vascular angiography
- Ability to take at least one of the following types of medications: anti- platelet or anti-thrombotic therapy
Who cannot join
- Patient has cardiac or cardiovascular comorbidities that would make surgery inappropriate
- Patient has terminal or Stage 4 cancer
- Patient has extensive gangrene that requires both a Below-the-Knee amputation and a revascularization procedure
- Previous stent in the target lesion
- Active infection at planned incision site
- The patient is a pregnant woman
- The patient has significant suprainguinal or Common Femoral disease that can not be treated either prior to or during the index procedure
- Target Lesion is a Chronic Total Occlusion (CTO) that is greater than 15cm in length and has severe, continuous calcification
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
New Mexico Heart Institute, PA
Albuquerque, New Mexico, 87102
Vascular Surgery Associates
Baton Rouge, Louisiana, 70809
University of Alabama, Birmingham
Birmingham, Alabama, 35294
Beth Isreal (BIDMC)
Boston, Massachusetts, 02215
University of Chicago
Chicago, Illinois, 60637
Cleveland VAMC
Cleveland, Ohio, 44106
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Duke University Medical Center
Durham, North Carolina, 27712
Heart & Vascular Clinic of Northern Colorado
Fort Collins, Colorado, 80523
Hackensack University Medical Center
Hackensack, New Jersey, 07601
St. Vincent
Indianapolis, Indiana, 46260
University of Mississippi
Jackson, Mississippi, 39216
Los Angeles Cardiology/Good Samaritan
Los Angeles, California, 90017
Holmes Regional Medical Center
Melbourne, Florida, 32901
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
St. Vincent's Medical Center
New York, New York, 10011
NY Weill Cornell Medical Center
New York, New York, 10021
Columbia Presbyterian
New York, New York, 10604
Sentara Heart Hospital
Norfolk, Virginia, 23507
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Alegent Health Research Center
Omaha, Nebraska, 68152
Sacred Heart Hospital
Pensacola, Florida, 32504
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Rhode Island Hospital
Providence, Rhode Island, 02903
William Beaumont/Southeast Surgical
Royal Oak, Michigan, 48073
UC Davis Vascular Center
Sacramento, California, 95817
San Francisco VA Medical Center
San Francisco, California, 94121
Providence Hospital
Southfield, Michigan, 48075
Stanford University Medical Center/Palo Alto VA
Stanford, California, 94306
Madigan Army Medical Center
Tacoma, Washington, 98431
St. Vincent Hospital
Worchester, Massachusetts, 01608
About this study
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs
- Conditions
- Peripheral Vascular Diseases
- Being tested
- Bypass, Silverhawk Plaque Excision
- Keywords
- CLI, Critical Limb Ischemia, PAD, Peripheral Arterial Disease, Artherosclerosis, Leg Pain, Cardiovascular, Artherectomy, Bypass, Peripheral Bypass, PROOF
- Medical subject headings
- Peripheral Vascular Diseases, Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BypassProcedure or surgery
Silverhawk Plaque ExcisionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Major amputation-free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startOct 2006
Why it stopped: Company decision to halt study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseasesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- FoxHollow Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James F. McKinsey, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504088
- Sponsor's protocol ID
- FHT-P-06-003
- Acronym
- PROOF
- Status last verified
- Aug 2007
- First submitted
- 17 Jul 2007
- Last updated
- 20 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT00504088
- Acronym / sponsor ID
- PROOF / FHT-P-06-003
- Conditions
- Peripheral Vascular Diseases
- Keywords
- CLI, Critical Limb Ischemia, PAD, Peripheral Arterial Disease, Artherosclerosis, Leg Pain, Cardiovascular, Artherectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision to halt study
- Lead sponsor
- FoxHollow TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- First posted
- 19 Jul 2007 (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.
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs
Study design
- Primary purpose
- Treatment
- Allocation
- 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 (9 listed)
- Ischemic rest pain for more than 2 weeks or ulceration or gangrene of the foot or toes (Rutherford Becker Category 4, 5 or 6)
- Willing and able, as evaluated by the PI, to provide Informed Consent
- Willing to undergo up to 5 years of clinical follow up visits as scheduled
- Angiographic pattern of infrainguinal disease that can be reasonably managed either by surgery or plaque excision in the first instance
- Reconstitution of at least one patent target tibial segment below the knee which provides run-off to the foot
Key exclusion criteria (8 listed)
- Patient has cardiac or cardiovascular comorbidities that would make surgery inappropriate
- Patient has terminal or Stage 4 cancer
- Patient has extensive gangrene that requires both a Below-the-Knee amputation and a revascularization procedure
- Previous stent in the target lesion
- Active infection at planned incision site
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 |
|---|---|---|
| Bypass | Procedure or surgery | – |
| Silverhawk Plaque Excision | Procedure or surgery | – |
Primary outcome
Major amputation-free survival
Results and safety
The study was stopped early (reason given: Company decision to halt study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2008.
Related trials for Peripheral Vascular Diseases
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
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.
James F. McKinsey, M.D. principal investigator
Columbia University
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bypass and Silverhawk Plaque Excision in people with Peripheral Vascular Diseases, run by FoxHollow Technologies at 31 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 9 inclusion and 8 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: stopped early, as of the sponsor's last update on 20 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Company decision to halt study). Results are not available in the source record.
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?
Major amputation-free survival. 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 20 Aug 2008.