Thoracic Aortic AneurysmsNCT00435942
Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
A study testing Relay Thoracic Stent-Graft and Open Repair in people with Thoracic Aortic Aneurysms and and Penetrating Atherosclerotic Ulcers, run by Bolton Medical at 27 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft) through 1-year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Aneurysms, and Penetrating Atherosclerotic Ulcers
- What is being tested?
- Relay Thoracic Stent-Graft and Open Repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 27 sitesUnited States
- Study dates
- Jan 2007to 15 May 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with diagnosed descending thoracic aortic aneurysms or penetrating atherosclerotic ulcers
- Subjects who are at least 18 years of age
- Subjects whose anatomy can accommodate the Relay device
- Subjects who consent to participate
- Subjects who agree to comply with follow-up schedule
Who cannot join
- Subjects with non-aneurysm lesions
- Subjects with less than 1 year life expectancy
- Subjects who are pregnant
- Subjects with medical conditions that would complicate the endovascular procedure or confound the results (e.g., Marfan's Syndrome, prior repair in the thoracic aorta, severe coronary artery disease, morbid obesity, etc.)
- Subjects participating in another investigational study
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Albany Medical Center
Albany, New York, 12208
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
INOVA Fairfax Hospital
Falls Church, Virginia, 22042
University of Florida
Gainesville, Florida, 32610
East Carolina University
Greenville, North Carolina, 27834
Methodist Hospital
Houston, Texas, 77030
Clarian Cardiovascular
Indianapolis, Indiana, 46202
Indiana Heart Hospial
Indianapolis, Indiana, 46250
University of Miami
Miami, Florida, 33136
Baptist Cardiac and Vascular Institute
Miami, Florida, 33176
Aurora St. Luke's Hospital
Milwaukee, Wisconsin, 53215
New York Presbyterian Hospital --Columbia/Cornell University
New York, New York, 10032
Sentara Heart Hospital
Norfolk, Virginia, 23510
Hospital of the University of Pennsylvania/Penn Presbyterian
Philadelphia, Pennsylvania, 19104
Arizona Heart Hospital
Phoenix, Arizona, 85006
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
The Mayo Clinic
Rochester, Minnesota, 55905
Rockford Memorial Hospital
Rockford, Illinois, 61103
University of California-San Francisco
San Francisco, California, 94143
University of Washington
Seattle, Washington, 98105
University of Arizona
Tucson, Arizona, 85724
Washington Hospital Center
Washington D.C., District of Columbia, 20010-2975
About this study
Official title: Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies
The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft) through 1-year. Safety will be evaluated by comparing major adverse events through 1-year in subjects treated with the Relay Thoracic Stent-Graft to those who underwent surgical repair. Long term follow-up is conducted through 5 years.
- Being tested
- Relay Thoracic Stent-Graft, Open Repair
- Medical subject headings
- Aortic Aneurysm, Thoracic, Penetrating Atherosclerotic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relay Thoracic Stent-GraftDevice
implant
Open RepairProcedure or surgery
Open surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Endovascular Treatment arm to be implanted with Relay device Receives: Device: Relay Thoracic Stent-Graft |
| 2 | Active comparator | Surgical Control, underwent open repair Receives: Procedure: Open Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects
The primary effectiveness endpoint was freedom from major device-related adverse events [endoleak (Types I, III and IV), stent migration (> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair] at 1 year post-procedure.
The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.
Measured: 1 year
Primary Safety Endpoint: Distribution of Major Adverse Events
The primary safety endpoint was the distribution of participants experiencing at least 1 of the major adverse events (aneurysm-related mortality, stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, and wound healing complications) within 1 year post-procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionApr 2011
- Study completion15 May 2017
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.
- Other trials for Thoracic Aortic AneurysmsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bolton Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Farber, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435942
- Sponsor's protocol ID
- IP-0004-06
- Status last verified
- Aug 2017
- First submitted
- 14 Feb 2007
- Last updated
- 16 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies
- ClinicalTrials.gov ID
- NCT00435942
- Acronym / sponsor ID
- IP-0004-06
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Bolton MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 16 Feb 2007 (estimated)
- Results
- Posted 5 Sep 2017
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 Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft) through 1-year. Safety will be evaluated by comparing major adverse events through 1-year in subjects treated with the Relay Thoracic Stent-Graft to those who underwent surgical repair. Long term follow-up is conducted through 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Relay Thoracic Stent-GraftEndovascular Treatment arm to be implanted with Relay device |
| 2 | Active comparator | Procedure: Open RepairSurgical Control, underwent open repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with diagnosed descending thoracic aortic aneurysms or penetrating atherosclerotic ulcers
- Subjects who are at least 18 years of age
- Subjects whose anatomy can accommodate the Relay device
- Subjects who consent to participate
- Subjects who agree to comply with follow-up schedule
Key exclusion criteria (5 listed)
- Subjects with non-aneurysm lesions
- Subjects with less than 1 year life expectancy
- Subjects who are pregnant
- Subjects with medical conditions that would complicate the endovascular procedure or confound the results (e.g., Marfan's Syndrome, prior repair in the thoracic aorta, severe coronary artery disease, morbid obesity, etc.)
- Subjects participating in another investigational study
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 |
|---|---|---|
| Relay Thoracic Stent-Graftimplant | Device | 1 |
| Open RepairOpen surgery | Procedure or surgery | 2 |
Primary outcome
Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects
Time frame: 1 year
The primary effectiveness endpoint was freedom from major device-related adverse events [endoleak (Types I, III and IV), stent migration (> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair] at 1 year post-procedure. The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.
Primary Safety Endpoint: Distribution of Major Adverse Events
Time frame: 1 year
The primary safety endpoint was the distribution of participants experiencing at least 1 of the major adverse events (aneurysm-related mortality, stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, and wound healing complications) within 1 year post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mark Farber, MD principal investigator
University of North Carolina
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relay Thoracic Stent-Graft and Open Repair in people with Thoracic Aortic Aneurysms and and Penetrating Atherosclerotic Ulcers, run by Bolton Medical at 27 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 5 inclusion and 5 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 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2017). 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?
Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects (time frame: 1 year). 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 16 Jan 2018.