Thoracic Aortic AneurysmNCT01327742
Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
A study testing Relay Thoracic Stent-Graft in people with Thoracic Aortic Aneurysm and Penetrating Ulcers, run by Bolton Medical at 15 sites in United States.
Trial summary
This study is a continuation of the pivotal trial studying the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is being evaluated by the device-related adverse event rate of endovascular repair (via the 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 Aneurysm, Penetrating Ulcers
- What is being tested?
- Relay Thoracic Stent-Graft
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 15 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Subjects with diagnosed descending thoracic aneurysm or penetrating ulcer
- Subjects whose anatomy can accommodate the Relay device
- Subjects who consent to participate
- Subjects who agree to a follow-up schedule
Who cannot join
- Subjects with lesions other than thoracic aneurysm and penetrating ulcer
- Subjects with less than 1 year life expectancy
- Subjects who are pregnant
- Subjects with medical conditions that wold complicate the endovascular procedure or confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery disease)
- Subjects participating in another investigational study
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Michigan
Ann Arbor, Michigan, 48109
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina
Chapel Hill, North Carolina, 27599
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
University of Florida
Gainesville, Florida, 32610
East Carolina University
Greenville, North Carolina, 27834
Indiana Heart Hospital
Indianapolis, Indiana, 46250
Baptist Cardiac and Vascular Institute
Miami, Florida, 33176
Sentara Heart Hospital
Norfolk, Virginia, 23510
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Arizona Heart Hospital
Phoenix, Arizona, 85006
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University Washington
Seattle, Washington, 98105
Washington Hospital Center
Washington D.C., District of Columbia, 20010
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
This study is a continuation of the pivotal trial studying the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is being evaluated by the device-related adverse event rate of endovascular repair (via the Relay thoracic stent-graft) through 1 year. Safety is being evaluated by comparing major adverse events through 1 year in subjects treated with the Relay thoracic stent-graft to those who underwent surgical repair.
- Conditions
- Thoracic Aortic Aneurysm, Penetrating Ulcers
- Being tested
- Relay Thoracic Stent-Graft
- Keywords
- Relay, Thoracic, Aneurysm
- Medical subject headings
- Aortic Aneurysm, Thoracic, Penetrating Atherosclerotic Ulcer, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relay Thoracic Stent-GraftDevice
Device implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Aortic AneurysmStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Bolton Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327742
- Sponsor's protocol ID
- IP-0004-06 rev I
- Status last verified
- Nov 2012
- First submitted
- 31 Mar 2011
- Last updated
- 19 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. 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
- NCT01327742
- Acronym / sponsor ID
- IP-0004-06 rev I
- Conditions
- Thoracic Aortic Aneurysm, Penetrating Ulcers
- Keywords
- Relay, Thoracic, Aneurysm
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Bolton MedicalIndustry (pharma, biotech, devices)
- First posted
- 4 Apr 2011 (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.
This study is a continuation of the pivotal trial studying the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is being evaluated by the device-related adverse event rate of endovascular repair (via the Relay thoracic stent-graft) through 1 year. Safety is being evaluated by comparing major adverse events through 1 year in subjects treated with the Relay thoracic stent-graft to those who underwent surgical repair.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with diagnosed descending thoracic aneurysm or penetrating ulcer
- Subjects whose anatomy can accommodate the Relay device
- Subjects who consent to participate
- Subjects who agree to a follow-up schedule
Key exclusion criteria (5 listed)
- Subjects with lesions other than thoracic aneurysm and penetrating ulcer
- Subjects with less than 1 year life expectancy
- Subjects who are pregnant
- Subjects with medical conditions that wold complicate the endovascular procedure or confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery disease)
- 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-GraftDevice implant | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
15 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 in people with Thoracic Aortic Aneurysm and Penetrating Ulcers, run by Bolton Medical at 15 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 4 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: status not confirmed, as of the sponsor's last update on 19 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
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.
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 19 Nov 2012.