Abdominal Aortic AneurysmsPhase 1NCT01328197
Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
A Phase 1 study testing Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System in people with Abdominal Aortic Aneurysms, run by Bolton Medical at 6 sites in United States.
Trial summary
The primary goal of the study is to assess the safety and performance of the Treovance device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology can be treated with an acceptable adverse event rate and that the device performs as expected. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Abdominal Aortic Aneurysms
- What is being tested?
- Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2011to Jun 2017
- Phase
- Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement
- Subjects with an infrarenal AAA that is >/= 4.5 cm in diameter for males, or >/= 4.0 cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6 months
- Subjects who consent to participate
- Subjects who agree to comply with the follow-up schedule
Who cannot join
- Subjects with dissections, ruptured aneurysms, or symptomatic aneurysms
- Subjects with prior AAA repair
- Subjects with medical conditions that would complicate the endovascular procedure or confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery disease)
- Subjects who are pregnant or lactating
- Subjects participating in other investigational studies
- Subjects with less than 2 years life expectancy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Carolinas Sanger Heart and Vascular
Charlotte, North Carolina, 28203
Spectrum Health System
Grand Rapids, Michigan, 49503
East Carolina University
Greenville, North Carolina, 27834
Sentara Heart Hospital
Norfolk, Virginia, 22042
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
Official title: A Phase I Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
The primary goal of the study is to assess the safety and performance of the Treovance device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology can be treated with an acceptable adverse event rate and that the device performs as expected. The results of this study will permit the establishment of endpoints and clinical design for a subsequent U.S. trial.
- Conditions
- Abdominal Aortic Aneurysms
- Being tested
- Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System
- Keywords
- Treovance, aneurysm, AAA
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treovance Abdominal Aortic Stent-Graft with Navitel Delivery SystemDevice
Stent-graft implant
| Study group | Role | What they receive |
|---|---|---|
| Treovance | Experimental | Not described Receives: Device: Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
major morbidity and mortality
Measured: 1, 6, 12 months
Secondary outcomes (1)
Device performance
Rateof delivery/deployment success will be recorded. Rates of endoleak, patency, migration will be documented a 1, 6, 12 months
Measured: implant, 1, 6, and 12 months
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)
- Study startJun 2011
- Primary completionApr 2013
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- AAA device
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bolton Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328197
- Sponsor's protocol ID
- IP-0006-10
- Status last verified
- Dec 2017
- First submitted
- 31 Mar 2011
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT01328197
- Acronym / sponsor ID
- IP-0006-10
- Conditions
- Abdominal Aortic Aneurysms
- Keywords
- Treovance, aneurysm, AAA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bolton MedicalIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2017 (actual)
- 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.
The primary goal of the study is to assess the safety and performance of the Treovance device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology can be treated with an acceptable adverse event rate and that the device performs as expected. The results of this study will permit the establishment of endpoints and clinical design for a subsequent U.S. trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- AAA device
| Arm | Type | Receives |
|---|---|---|
| Treovance | Experimental | Device: Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement
- Subjects with an infrarenal AAA that is >/= 4.5 cm in diameter for males, or >/= 4.0 cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6 months
- Subjects who consent to participate
- Subjects who agree to comply with the follow-up schedule
Key exclusion criteria (6 listed)
- Subjects with dissections, ruptured aneurysms, or symptomatic aneurysms
- Subjects with prior AAA repair
- Subjects with medical conditions that would complicate the endovascular procedure or confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery disease)
- Subjects who are pregnant or lactating
- Subjects participating in other investigational studies
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 |
|---|---|---|
| Treovance Abdominal Aortic Stent-Graft with Navitel Delivery SystemStent-graft implant | Device | Treovance |
Primary outcome
major morbidity and mortality
Time frame: 1, 6, 12 months
1 secondary outcome
Device performance
Time frame: implant, 1, 6, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System in people with Abdominal Aortic Aneurysms, run by Bolton Medical at 6 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 6 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 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 morbidity and mortality (time frame: 1, 6, 12 months). 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 Dec 2017.