Abdominal Aortic AneurysmsPhase 2UNITENCT00610090
Safety Study for the Treatment of Abdominal Aortic Aneurysms
A Phase 2 study testing UniFit AAA Stent Graft in people with Abdominal Aortic Aneurysms, run by Duke Vascular, Inc. at 19 sites in United States.
Trial summary
The primary study objective, at this time, is to follow out to 5 years post implant the safety of already enrolled subjects who were treated with the UniFit Aorto-uni-iliac (AUI) Endoluminal Stent Graft (the "study device") for the repair of abdominal aortic aneurysms (AAAs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms
- What is being tested?
- UniFit AAA Stent Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 19 sitesUnited States
- Study dates
- May 2007to Dec 2015
- Phase
- Phase 2
- 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
- Patient is 18 years of age or older
- Patient has a AAA that meets one of the following criteria:
- Aneurysm diameter of greater than 4.5 cm, or less than 4.5 cm with rapid expansion
- The aneurysm has a saccular configuration where potential for rupture is increased or has exhibited dissection with potential for rupture at, or compromised flow to, vital structures
- The vessels immediately proximal and distal to the lesion are capable of accommodating the study device
- The access artery diameter and profile of the artery are capable of study device delivery.
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- Patient has proximal and distal neck lengths of greater than or equal to 1.0 cm
- Patient is willing and able to comply with the follow-up regime.
- Patient has provided written informed consent.
Who cannot join
- Patient has an aortic diameter greater than 36 mm.
- Patients with ASA score less than 3 and deemed low risk by the Investigator for open surgical repair.
- Patient has an indispensable inferior mesenteric artery.
- Patient has a distal landing zone of < 2 cm in length or > 16 mm in diameter
- Patient has iliac arteries whose tortuosity prevents passage of the introducer catheter.
- If female, patient is pregnant
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- Patient has a life expectancy less than two years.
- Patient has an allergy to any of the study device materials
- Patient has coagulopathy or bleeding disorders
- Patient for whom contrast medium or anticoagulation drugs are contraindicated
- Patient has an uncontained rupture of the aneurysm.
- Patient has an active systemic or localized groin infection
- Patient has a connective tissue disease.
- Patient has a GFR < 30 ml/min/1.73m2
- Patient has a circumferential mural thrombus at the implantation site.
- Patient is a candidate for a bifurcated endovascular graft.
- Patient has an aortic trunk with an angle greater than 90°.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Albany Medical Center Hospital
Albany, New York, 12208
Emory University
Atlanta, Georgia, 30322
Iowa Heart Center
Des Moines, Iowa, 50266
Englewood Hospital
Englewood, New Jersey, 07631
Inova Fairfax Hospital
Fairfax, Virginia, 22042
Indiana University Hospital
Indianapolis, Indiana, 46206
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Loma Linda VA
Loma Linda, California, 92354
Christiana Hospital
Newark, Delaware, 19713
Sentara Healthcare, Vascular and Transplant Specialists
Norfolk, Virginia, 23507
Florida Hospital
Orlando, Florida, 32803
Sacred Heart Hospital
Pensacola, Florida, 32504
Dotter Interventional Institute
Portland, Oregon, 97239
William Beaumont Hospital
Royal Oak, Michigan, 48073
Savannah Vascular Institute
Savannah, Georgia, 31404
Scott and White Hospital
Temple, Texas, 76508
UCLA Medical Center
Torrance, California, 90502
Southwest Washington Medical Center
Vancouver, Washington, 98664
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: A Phase II, Single-arm, Prospective Study of the Safety of the UniFit Aorto-uni-iliac Endoluminal Stent Graft for the Repair of Abdominal Aortic Aneurysms
The primary study objective, at this time, is to follow out to 5 years post implant the safety of already enrolled subjects who were treated with the UniFit Aorto-uni-iliac (AUI) Endoluminal Stent Graft (the "study device") for the repair of abdominal aortic aneurysms (AAAs).
Read the detailed description
This is a phase II, single-arm, prospective study of the safety of the study device for the repair of AAAs.
The investigator will identify eligible patients and explain the study and study device placement procedure to each patient and/or any available family members. Patients who provide written informed consent will be evaluated for study eligibility within the time period identified under Duration of Treatment. Patients who are confirmed to be eligible, based on screening assessment findings, will be enrolled in the study.
After hospital discharge, patients will attend study center visits at 30 days, 6 months, and 1, 2, 3, 4, and 5 years post-procedure for follow-up evaluations.
- Conditions
- Abdominal Aortic Aneurysms
- Being tested
- UniFit AAA Stent Graft
- Keywords
- UNITE, AAA, Abdominal Aortic Aneurysms, Stent, Graft
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UniFit AAA Stent GraftDevice
Also called UniFit, Unite Trial
Endovascular repair of Abdominal Aortic Aneurysms
| Study group | Role | What they receive |
|---|---|---|
| Treatment - UniFit AAA Stent Graft | Experimental | Not described Receives: Device: UniFit AAA Stent Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
The primary objective, at this time, is to ensure the safety of already enrolled and treated subjects. The data resulting from this study will not be used for any regulatory or commercialization purpose.
The current sponsor, Duke Vascular, Inc. is requesting closure of this IDE
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startMay 2007
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke Vascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610090
- Sponsor's protocol ID
- LMV-AUI-P2-001
- Acronym
- UNITE
- Status last verified
- May 2015
- First submitted
- 24 Jan 2008
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-arm, Prospective Study of the Safety of the UniFit Aorto-uni-iliac Endoluminal Stent Graft for the Repair of Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT00610090
- Acronym / sponsor ID
- UNITE / LMV-AUI-P2-001
- Conditions
- Abdominal Aortic Aneurysms
- Keywords
- UNITE, AAA, Abdominal Aortic Aneurysms, Stent, Graft
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Duke Vascular, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 7 Feb 2008 (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 study objective, at this time, is to follow out to 5 years post implant the safety of already enrolled subjects who were treated with the UniFit Aorto-uni-iliac (AUI) Endoluminal Stent Graft (the "study device") for the repair of abdominal aortic aneurysms (AAAs).
Detailed description
This is a phase II, single-arm, prospective study of the safety of the study device for the repair of AAAs.
The investigator will identify eligible patients and explain the study and study device placement procedure to each patient and/or any available family members. Patients who provide written informed consent will be evaluated for study eligibility within the time period identified under Duration of Treatment. Patients who are confirmed to be eligible, based on screening assessment findings, will be enrolled in the study.
After hospital discharge, patients will attend study center visits at 30 days, 6 months, and 1, 2, 3, 4, and 5 years post-procedure for follow-up evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment - UniFit AAA Stent Graft | Experimental | Device: UniFit AAA Stent Graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient is 18 years of age or older
- Patient has a AAA that meets one of the following criteria:
- The vessels immediately proximal and distal to the lesion are capable of accommodating the study device
- The access artery diameter and profile of the artery are capable of study device delivery.
- Patient has proximal and distal neck lengths of greater than or equal to 1.0 cm
Key exclusion criteria (17 listed)
- Patient has an aortic diameter greater than 36 mm.
- Patients with ASA score less than 3 and deemed low risk by the Investigator for open surgical repair.
- Patient has an indispensable inferior mesenteric artery.
- Patient has a distal landing zone of < 2 cm in length or > 16 mm in diameter
- Patient has iliac arteries whose tortuosity prevents passage of the introducer catheter.
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 |
|---|---|---|
| UniFit AAA Stent GraftAlso: UniFit, Unite TrialEndovascular repair of Abdominal Aortic Aneurysms | Device | Treatment - UniFit AAA Stent Graft |
Primary outcome
Primary Objective
Time frame: 5 year
The primary objective, at this time, is to ensure the safety of already enrolled and treated subjects. The data resulting from this study will not be used for any regulatory or commercialization purpose. The current sponsor, Duke Vascular, Inc. is requesting closure of this IDE
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
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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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UniFit AAA Stent Graft in people with Abdominal Aortic Aneurysms, run by Duke Vascular, Inc. at 19 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 9 inclusion and 17 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 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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. 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?
Primary Objective (time frame: 5 year). 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 Aug 2015.