Cryptogenic StrokeNCT00465270
Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
A study testing AMPLATZER PFO Occluder in people with Cryptogenic Stroke, run by Abbott Medical Devices at 69 sites in 2 countries.
Trial summary
The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cryptogenic Stroke
- What is being tested?
- AMPLATZER PFO Occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 980 participants
- Where
- 69 sitesin 2 countries
- Study dates
- Aug 2003to May 2016
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who have had a cryptogenic stroke within the last 270 days
- Subjects who have been diagnosed with a Patent Foramen Ovale (PFO)
- Subjects willing to participate in follow-up visits
Who cannot join
- Subjects with intracardiac thrombus or tumor
- Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina
- Subjects with left ventricular aneurysm or akinesis
- Subjects with atrial fibrillation/atrial flutter (chronic or intermittent)
- Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum
- Subjects with contraindication to aspirin or Clopidogrel therapy
- Pregnant or desire to become pregnant within the next year
Trial locations and contacts
69 sites in 2 countries.
69 sites in 2 countries
United States61 sites
Neurology and Neuroscience Associates
Akron, Ohio, 44320
Albany Medical Center
Albany, New York, 12208
LeHigh Valley Hospital
Allentown, Pennsylvania, 18105
DENT Neurologic Institute
Amherst, New York, 14226
University of Michigan Health System
Ann Arbor, Michigan, 48109-0316
University of Alabama
Birmingham, Alabama, 35249
Tufts Medical Center
Boston, Massachusetts, 02111
Medical University of South Carolina
Charleston, South Carolina, 29425
Charleston Area Medical Center
Charleston, West Virginia, 25304
Our Lady of Lourdes Medical Center
Cherry Hill, New Jersey, 08034
Northwestern University
Chicago, Illinois, 60611-3078
University of Chicago
Chicago, Illinois, 60637-1470
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Ohio State University
Columbus, Ohio, 43210
UT Southwestern Medical School
Dallas, Texas, 75390-8897
University of Colorado
Denver, Colorado, 80262
Ruan Neurology
Des Moines, Iowa, 50314
St. Mary's Duluth Clinic
Duluth, Minnesota, 55805
Duke University Medical Center
Durham, North Carolina, 27710
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27410
Penn State Milton South Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Texas Houston Health Science Center
Houston, Texas, 77030
Indiana Heart Physicians
Indianapolis, Indiana, 46237
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
St. Vincent's Medical Center
Jacksonville, Florida, 32204
Kansas University Medical Center
Kansas City, Kansas, 66160
Lancaster General Hospital
Lancaster, Pennsylvania, 17543
St. Mary's Medical Center
Langhorne, Pennsylvania, 19067
University of Kentucky
Lexington, Kentucky, 40536
South Denver Cardiology Associates
Littleton, Colorado, 80120
LAC + USC Medical Center
Los Angeles, California, 90033
UCLA
Los Angeles, California, 90095
Medical Center of the Rockies
Loveland, Colorado, 80538
University of Wisconsin Hospital
Madison, Wisconsin, 53792
Marshfield Clinic
Marshfield, Wisconsin, 54449
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
University of Minnesota
Minneapolis, Minnesota, 55455
St. Thomas Neurology
Nashville, Tennessee, 37205
Vanderbilt University
Nashville, Tennessee, 37232-8802
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
University of Medicine and Dentistry of New Jersy
Newark, New Jersey, 07103
Summit Medical Center
Oakland, California, 94609
University of Nebraska Medical Center
Omaha, Nebraska, 68198-2045
Neurologic Associates Inc
Palos Heights, Illinois, 60463
OSF St. Francis Medical Center
Peoria, Illinois, 61637
Providence St. Vincent's Medical Center
Portland, Oregon, 97225
Oregon Stroke Center, OHSU
Portland, Oregon, 97329
University of Rochester
Rochester, New York, 14642
Methodist Hospital/Park Nicollet Medical Center
Saint Louis Park, Minnesota, 55426
Sharp Memorial Hospital
San Diego, California, 92123
Kaiser Permanente
San Francisco, California, 94115
Mayo Clinic
Scottsdale, Arizona, 85259
UW Medicine Stroke Center
Seattle, Washington, 98104
North Central Heart Institute
Sioux Falls, South Dakota, 57108
Southern Illinois University Neurology
Springfield, Illinois, 62702
Washington University
St Louis, Missouri, 63110
Midatlantic Cardiovascular Associates
Towson, Maryland, 21014
Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, 23454
Washington Hospital Center
Washington D.C., District of Columbia, 20010
George Washington University Hospital
Washington D.C., District of Columbia, 20037
Canada8 sites
University of Calgary
Calgary, Alberta, T2N 2T9
University of Alberta
Edmonton, Alberta, T6G 2B7
Stroke Prevention & Atherosclerosis Research Center (SPARC) - Robarts Research Institute
London, Ontario, N6G 2V2
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W5
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
St. Paul's Hospital
Vancouver, British Columbia, V5Z 1Y6
About this study
Official title: Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT)
The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.
Read the detailed description
The AMPLATZER PFO Occluder is a percutaneous, transcatheter occlusion device intended for the non-surgical closure of patent foramen ovale in subjects who have had a cryptogenic stroke due to presumed paradoxical embolism within the last 270 days.
- Conditions
- Cryptogenic Stroke
- Being tested
- AMPLATZER PFO Occluder, Standard of Care - Medical Management
- Keywords
- Cryptogenic, Stroke, PFO, Patent foramen ovale, AMPLATZER, Occluder
- Medical subject headings
- Ischemic Stroke, Stroke, Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMPLATZER PFO OccluderDevice
patent foramen ovale closure device
Standard of Care - Medical ManagementOther
Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | AMPLATZER PFO Occluder Receives: Device: AMPLATZER PFO Occluder |
| Standard or Care - Medical Management | Active comparator | Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole. Receives: Other: Standard of Care - Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization
Nonfatal stroke is defined as: focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT imaging findings of a new, neuroanatomically relevent, cergral infarct.
Post-randomization death is defined as: in the MM group as all-cause mortality within 45 days after randomization, and in the device group as all-cause mortality 30 days after implant or 45 days after randomizaiton, whichever occurs last.
Measured: Trial enrollment was stopped once 25 unique subjects were mutually adjudicated by the CEC and DSMB as having experienced a primary endpoint event. This occurred on December 20, 2011. The mean follow-up time was 2.6 years.
Secondary outcomes (1)
Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2007 (estimated)
- Study startAug 2003
- Primary completionMay 2012
- Study completionMay 2016
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 (2)Papers the sponsor has linked to this study.
- Other trials for Cryptogenic StrokeStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- AMPLATZER PFO Occluder
- Masking
- None (open label)
- Enrolment
- 980 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Saver, MD, Principal investigator, UCLA Stroke CenterJohn D Carroll, MD, Principal investigator, University of Colorado, DenverRichard Smalling, MD, Principal investigator, University of Texas Houston Health Science CenterDavid Thaler, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465270
- Sponsor's protocol ID
- AGA-006
- Other IDs
- G990318
- Status last verified
- Jan 2019
- First submitted
- 23 Apr 2007
- Last updated
- 18 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Expanded access
- Available
Publications
Saver JL, Carroll JD, Thaler DE, Smalling RW, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke. N Engl J Med. 2017 Sep 14;377(11):1022-1032. doi: 10.1056/NEJMoa1610057.
PubMed 28902590Carroll JD, Saver JL, Thaler DE, Smalling RW, Berry S, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med. 2013 Mar 21;368(12):1092-100. doi: 10.1056/NEJMoa1301440.
PubMed 23514286
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT)
- ClinicalTrials.gov ID
- NCT00465270
- Acronym / sponsor ID
- AGA-006
- Conditions
- Cryptogenic Stroke
- Keywords
- Cryptogenic, Stroke, PFO, Patent foramen ovale, AMPLATZER, Occluder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 980 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Aug 2003 (actual)
- Primary completion
- May 2012 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 24 Apr 2007 (estimated)
- Results
- Posted 4 Sep 2018
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 investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.
Detailed description
The AMPLATZER PFO Occluder is a percutaneous, transcatheter occlusion device intended for the non-surgical closure of patent foramen ovale in subjects who have had a cryptogenic stroke due to presumed paradoxical embolism within the last 270 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- AMPLATZER PFO Occluder
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: AMPLATZER PFO OccluderAMPLATZER PFO Occluder |
| Standard or Care - Medical Management | Active comparator | Other: Standard of Care - Medical ManagementMedical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects who have had a cryptogenic stroke within the last 270 days
- Subjects who have been diagnosed with a Patent Foramen Ovale (PFO)
- Subjects willing to participate in follow-up visits
Key exclusion criteria (7 listed)
- Subjects with intracardiac thrombus or tumor
- Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina
- Subjects with left ventricular aneurysm or akinesis
- Subjects with atrial fibrillation/atrial flutter (chronic or intermittent)
- Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum
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 |
|---|---|---|
| AMPLATZER PFO Occluderpatent foramen ovale closure device | Device | Device |
| Standard of Care - Medical ManagementMedical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole | Other | Standard or Care - Medical Management |
Primary outcome
Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization
Time frame: Trial enrollment was stopped once 25 unique subjects were mutually adjudicated by the CEC and DSMB as having experienced a primary endpoint event. This occurred on December 20, 2011. The mean follow-up time was 2.6 years.
Nonfatal stroke is defined as: focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT imaging findings of a new, neuroanatomically relevent, cergral infarct. Post-randomization death is defined as: in the MM group as all-cause mortality within 45 days after randomization, and in the device group as all-cause mortality 30 days after implant or 45 days after randomizaiton, whichever occurs last.
1 secondary outcome
Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28902590Saver JL, Carroll JD, Thaler DE, Smalling RW, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke. N Engl J Med. 2017 Sep 14;377(11):1022-1032. doi: 10.1056/NEJMoa1610057.
- Background: PubMed 23514286Carroll JD, Saver JL, Thaler DE, Smalling RW, Berry S, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med. 2013 Mar 21;368(12):1092-100. doi: 10.1056/NEJMoa1301440.
- Related InfoLink provided by the sponsor.
Related trials for Cryptogenic Stroke
Recruiting
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
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Not yet recruiting
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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NeuroAiD Patient-Reported Outcomes in Patients With Mild to Moderate Ischemic Stroke
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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.
Jeffrey Saver, MD principal investigator
UCLA Stroke Center
John D Carroll, MD principal investigator
University of Colorado, Denver
Richard Smalling, MD principal investigator
University of Texas Houston Health Science Center
69 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMPLATZER PFO Occluder in people with Cryptogenic Stroke, run by Abbott Medical Devices at 69 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 3 inclusion and 7 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 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States, Canada. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2018). 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?
Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization (time frame: Trial enrollment was stopped once 25 unique subjects were mutually adjudicated by the CEC and DSMB as having experienced a primary endpoint event. This occurred on December 20, 2011. The mean follow-up time was 2.6 years.). 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 NCT00465270, which also lists 2 linked publications.
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 18 Feb 2019.