Carotid StenosisPhase 2/3NCT00395785
Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting
A Phase 2/3 study testing Carotid Stent Implantation and Embolic Protection in people with Carotid Stenosis, run by Kensey Nash Corporation at 34 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the TriActiv® ProGuard™ System when used during a stent placement in a blockage within the carotid artery in patients considered to be at high risk for complications from surgical endarterectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Carotid Stent Implantation and Embolic Protection
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 34 sitesin 2 countries
- Study dates
- Nov 2006to Jun 2007
- Phase
- Phase 2/3
- 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
- Greater than 18 year of age
- Patient gives informed consent
- Less than 30mm stenosis in the common and/or internal carotid artery: at least a 50% stenosis if symptomatic or at least an 80% stenosis if asymptomatic
- At least one medical or anatomic condition which makes the patient a high surgical risk.
Who cannot join
- Stroke within 14 days
- Major stroke with significant residual effects
- Myocardial infarction within 72 hours
- Extensive atherosclerotic disease in the aortic arch or proximal common carotid artery
- Severe carotid artery tortuosity
- Total occlusion
Show all 12Show fewer
- Presence of thrombus or heavy calcification in the carotid artery
- Pre-existing carotid artery dissection
- Any planned interventional or surgical procedures within 30 days
- Atrial fibrillation
- Creatinine > 2 mg/dL
- Current participation in another investigational drug or device study
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United States31 sites
Piedmont Hospital
Atlanta, Georgia, 30309
Crawford Long Hospital
Atlanta, Georgia, 30322
Emory University Hospital
Atlanta, Georgia, 30322
Florida Crdiovascular Research at JFK Medical Center
Atlantis, Florida, 33462
Brotman Medical Center
Beverly Hills, California, 90210
University of Alabama Birmingham
Birmingham, Alabama, 35294-0012
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Millard Fillmore Hospital
Buffalo, New York, 14209
Millard Fillmore
Buffalo, New York, 14209
Cleveland Clinic
Cleveland, Ohio, 44195
Sisters of Charity Providence Hospital
Columbia, South Carolina, 29204
Lorain Community Hospital
Elyria, Ohio, 44035
Thomas Hospital
Fairhope, Alabama, 36532
Methodist Germantown
Germantown, Tennessee, 38138
Pinnacle Health Hospital
Harrisburg, Pennsylvania, 17110
University of Florida
Jacksonville, Florida, 32209
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660
Baptist Hospital of East Tennessee
Knoxville, Tennessee, 37920
Good Samaritan Hospital
Los Angeles, California, 90017
Jewish Hospital
Louisville, Kentucky, 40202
North Shore University Hospital
Manhasset, New York, 11030
Baptist Hospital of Miami
Miami, Florida, 33176
Mt. Sinai Medical Center
Miami Beach, Florida, 33140
El Camino Hospital
Mountain View, California, 94040
Lenox Hill Hospital
New York, New York, 10021
Virginia Cardiovascular Specialists/St. Mary's Hospital
Richmond, Virginia, 23226
LDS Hospital
Salt Lake City, Utah, 84143
Stanford University Medical Center
Stanford, California, 94305
St. John West Shore Hospital
Westlake, Ohio, 44145
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
St. Joseph Medical Center
Wyomissing, Pennsylvania, 19610
Germany3 sites
Stadtisches Krankenhaus Neuperlach
Bayern, 81737
CardioVasculares Centrum Frankfurt Sankt Katharinen
Frankfurt, 60389
Herzzentrum Hamburg
Hamburg, 22527
About this study
Official title: Protection During Carotid Stenting in High Risk Patients With the TriActiv ProGuard System
The purpose of this study is to evaluate the safety and efficacy of the TriActiv® ProGuard™ System when used during a stent placement in a blockage within the carotid artery in patients considered to be at high risk for complications from surgical endarterectomy.
Read the detailed description
Patients with certain anatomic or medical conditions have a greater risk of serious complications following carotid endarterectomy (a surgical procedure that removes blockages in the carotid artery). Recently, these patients have been treated effectively with the implantation of a carotid stent (a metallic mesh tube). When implanting the carotid stent, physicians use devices called embolic protection devices to prevent particles from the blockage from flowing up to the brain. The TriActiv® ProGuard™ System is an embolic protection device that uses a small balloon to temporarily stop blood flow within the diseased carotid artery while the stent is implanted. Then, the TriActiv® ProGuard™ System removes any particles that may have been released from the blockage during stent implantation before blood flow is restored. This study will evaluate the safety and efficacy of the TriActiv® ProGuard™ System during carotid stent placement in patients who are considered to be at a high risk for complications from surgical endarterectomy.
- Conditions
- Carotid Stenosis
- Being tested
- Carotid Stent Implantation, Embolic Protection
- Keywords
- Carotid stenosis, Intracranial Embolism, Carotid artery, Carotid stent, Embolic protection, TriActiv ProGuard System, Carotid angioplasty
- Medical subject headings
- Carotid Stenosis, Intracranial Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Stent ImplantationDevice
Embolic ProtectionDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of major adverse events including any death, any stroke and/or myocardial infarction through thirty days post-procedure.
Secondary outcomes (5)
Rate of subject intolerance to prolonged carotid artery occlusion;
Rate of access site complications requiring treatment with blood transfusion or surgical repair.
Rate of successful use of the study device success
Rate of successful lesion treatment
Rate of procedure success
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2006 (estimated)
- Study startNov 2006
- Study completionJun 2007
Why it stopped: Sponsor elected to not pursue this indication for the study device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kensey Nash Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gary S Roubin, MD, Principal investigator, Lenox Hill Hospital, New York, NYRajesh Dave, MD, Principal investigator, Pinnacle Health Hospital, Harrisburg, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395785
- Sponsor's protocol ID
- PROGUARD
- Status last verified
- Jul 2007
- First submitted
- 1 Nov 2006
- Last updated
- 25 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protection During Carotid Stenting in High Risk Patients With the TriActiv ProGuard System
- ClinicalTrials.gov ID
- NCT00395785
- Acronym / sponsor ID
- PROGUARD
- Conditions
- Carotid Stenosis
- Keywords
- Carotid stenosis, Intracranial Embolism, Carotid artery, Carotid stent, Embolic protection, TriActiv ProGuard System, Carotid angioplasty
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor elected to not pursue this indication for the study device.
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Kensey Nash CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 3 Nov 2006 (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.
The purpose of this study is to evaluate the safety and efficacy of the TriActiv® ProGuard™ System when used during a stent placement in a blockage within the carotid artery in patients considered to be at high risk for complications from surgical endarterectomy.
Detailed description
Patients with certain anatomic or medical conditions have a greater risk of serious complications following carotid endarterectomy (a surgical procedure that removes blockages in the carotid artery). Recently, these patients have been treated effectively with the implantation of a carotid stent (a metallic mesh tube). When implanting the carotid stent, physicians use devices called embolic protection devices to prevent particles from the blockage from flowing up to the brain. The TriActiv® ProGuard™ System is an embolic protection device that uses a small balloon to temporarily stop blood flow within the diseased carotid artery while the stent is implanted. Then, the TriActiv® ProGuard™ System removes any particles that may have been released from the blockage during stent implantation before blood flow is restored. This study will evaluate the safety and efficacy of the TriActiv® ProGuard™ System during carotid stent placement in patients who are considered to be at a high risk for complications from surgical endarterectomy.
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 (4 listed)
- Greater than 18 year of age
- Patient gives informed consent
- Less than 30mm stenosis in the common and/or internal carotid artery: at least a 50% stenosis if symptomatic or at least an 80% stenosis if asymptomatic
- At least one medical or anatomic condition which makes the patient a high surgical risk.
Key exclusion criteria (12 listed)
- Stroke within 14 days
- Major stroke with significant residual effects
- Myocardial infarction within 72 hours
- Extensive atherosclerotic disease in the aortic arch or proximal common carotid artery
- Severe carotid artery tortuosity
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 |
|---|---|---|
| Carotid Stent Implantation | Device | – |
| Embolic Protection | Device | – |
Primary outcome
A composite of major adverse events including any death, any stroke and/or myocardial infarction through thirty days post-procedure.
5 secondary outcomes
Rate of subject intolerance to prolonged carotid artery occlusion;
Rate of access site complications requiring treatment with blood transfusion or surgical repair.
Rate of successful use of the study device success
Rate of successful lesion treatment
Rate of procedure success
Results and safety
The study was stopped early (reason given: Sponsor elected to not pursue this indication for the study device.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2007.
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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.
Gary S Roubin, MD principal investigator
Lenox Hill Hospital, New York, NY
Rajesh Dave, MD principal investigator
Pinnacle Health Hospital, Harrisburg, PA
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Carotid Stent Implantation and Embolic Protection in people with Carotid Stenosis, run by Kensey Nash Corporation at 34 sites in 2 countries.
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 4 inclusion and 12 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 25 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Germany. 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 combined 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.
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 was stopped early (reason given: Sponsor elected to not pursue this indication for the study device.). 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?
A composite of major adverse events including any death, any stroke and/or myocardial infarction through thirty days post-procedure.. 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 25 Jul 2007.