Abdominal Aortic AneurysmsNCT00604643
Talent Aortic Cuff Stent Graft System Compassionate Use Registry
A study testing TALENT Aortic Cuff Abdominal Stent Graft in people with Abdominal Aortic Aneurysms, run by Medtronic Cardiovascular at 50 sites in United States.
Trial summary
An evaluation of the TALENT Aortic Cuff in patients with existing AneuRx stent grafts who have experienced sub-optimal stent graft outcomes and are not deemed suitable candidates for treatment with an AneuRx Aortic Cuff. 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?
- TALENT Aortic Cuff Abdominal Stent Graft
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 50 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient >= 18 years of age
- Patient has a serious disease or condition
- No generally acceptable alternative for treating patient is available
- Patient has had the AneuRx stent graft system implanted >= 30 days
- Patient has suboptimal outcome with the AneuRx stent graft system as evidenced by one or more of the following:
- Type I endoleak
Show all 11Show fewer
- Type III endoleak (Proximal, modular)
- Loss of seal zone
- Proximal aortic neck diameter >= 14mm and <= 30mm
- Angle between axis of the suprarenal aorta and aneurysm neck is <= 60 degrees
- Patient is able and willing to be available for 12,24,26,48 and 60 months post-procedure
Who cannot join
- Patient is pregnant of lactating
- Arterial access cannot be crossed with a delivery system
- Excessive vessel tortuosity
- Excessive aortic calcification
- AneuRx stent graft system implanted within the last 30 days
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 sites
NMVA Healthcare
Albuquerque, New Mexico, 87108
Mission Hospital
Asheville, North Carolina, 28801
St. Joseph's Hospital
Atlanta, Georgia, 30342
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
University of Vermont
Burlington, Vermont, 05402
The Sanger Clinic-Carolinas Medical
Charlotte, North Carolina, 28203
Kaiser Sunnyside
Clackamas, Oregon, 97015
Morton Plant Hospital
Clearwater, Florida, 33757
Penrose Healthcare
Colorado Springs, Colorado, 80907
Providence Hospital
Columbia, South Carolina, 29204
Iowa Heart Center
Des Moines, Iowa, 50314
North Florida Regional Medical Center
Gainesville, Florida, 32605
University of Florida
Gainesville, Florida, 32610
Harlingen Medical Center
Harlingen, Texas, 78550
Pinnacle Health Hospital
Harrisburg, Pennsylvania, 17101
Hartford Hospital
Hartford, Connecticut, 06102
St. Luke's Episcopal Hospital
Houston, Texas, 77030
Houston Northwest Medical Center
Houston, Texas, 77090
CV Surgical Clinic
Jackson, Mississippi, 39202
St. Dominic-Jackson
Jackson, Mississippi, 39202
St. Luke's
Kansas City, Missouri, 64111
LaGrange Memorial Hospital
La Grange, Illinois, 60525
Southwest Medical Center
Lafayette, Louisiana, 70506
Gwinnett Hospital
Lawrenceville, Georgia, 30045
Dartmouth-Hitchcock
Lebanon, New Hampshire, 03756
University of Kentucky medical Center
Lexington, Kentucky, 40536
Baptist Hospital
Louisville, Kentucky, 40207
Jeff Anderson Regional Medical Center
Meridian, Mississippi, 39301
St. Luke's medical Center
Milwaukee, Wisconsin, 53215
Baptist Hospital
Montgomery, Alabama, 36116
Kaiser
Oakland, California, 94611
Munroe Regional Medical Center
Ocala, Florida, 34474
Hahnemann Univeristy Hospital
Philadelphia, Pennsylvania, 19102
Graduate Hospital
Philadelphia, Pennsylvania, 19146
Henrico Doctors' Hospital
Richmond, Virginia, 23229
Bon Secours Cottage Health Center
Saint Clair Shores, Michigan, 48081
St. Cloud Hospital
Saint Cloud, Minnesota, 56303
Lakeland Regional Medical Center
Saint Joseph, Michigan, 49085
Health Easst St. Joseph's Hospital
Saint Paul, Minnesota, 55105
O'Connor Hospital
San Jose, California, 95128
North Central heart Institute
Sioux Falls, South Dakota, 57108
Washington University School of Medicine
St Louis, Missouri, 63110
St. John's Mercy Medical Center
St Louis, Missouri, 63141
JA Haley Veterans Hospital
Tampa, Florida, 33612
Kaiser Hayward
Union City, California, 94587
St. Luke's Healthcare
Utica, New York, 13502
Washington Hospital
Washington D.C., District of Columbia, 20010
Lexington Medical Center
West Columbia, South Carolina, 29169
Via Christi Regional Medical center
Wichita, Kansas, 67214
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
Official title: Compassionate Use of the TALENT Aortic Cuff in the Treatment of Patients Previously Treated With the AneuRx Stent Graft System With Sub-Optimal Stent Graft Outcomes
An evaluation of the TALENT Aortic Cuff in patients with existing AneuRx stent grafts who have experienced sub-optimal stent graft outcomes and are not deemed suitable candidates for treatment with an AneuRx Aortic Cuff.
Read the detailed description
The primary purpose of this registry is to provide an endovascular means of treatment for those patients experiencing a sub-optimal outcome related to the implanted AneuRx bifurcated stent graft and who are not deemed suitable candidates for treatment with an AneuRx Aortic Cuff. A sub-optimal outcome is defined as either a Type I or Type III endoleak and/or an inadequate seal zone (< 1 cm). For Registry purposes, a Type III endoleak will be defined as a proximal modular endoleak.
- Conditions
- Abdominal Aortic Aneurysms
- Being tested
- TALENT Aortic Cuff Abdominal Stent Graft
- Keywords
- Abdominal Aneurysm, Endovascular Aortic Repair (EVAR), Endovascular Stent Graft, Endograft
- 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.
TALENT Aortic Cuff Abdominal Stent GraftDevice
Endovascular Aneurysm Repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (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.
- More trials run by Medtronic CardiovascularThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medtronic CardioVascular, Study director, Medtronic Cardiovascular
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604643
- Sponsor's protocol ID
- Investigational Plan #025
- Status last verified
- Oct 2021
- First submitted
- 21 Dec 2007
- Last updated
- 2 Nov 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of the TALENT Aortic Cuff in the Treatment of Patients Previously Treated With the AneuRx Stent Graft System With Sub-Optimal Stent Graft Outcomes
- ClinicalTrials.gov ID
- NCT00604643
- Acronym / sponsor ID
- Investigational Plan #025
- Conditions
- Abdominal Aortic Aneurysms
- Keywords
- Abdominal Aneurysm, Endovascular Aortic Repair (EVAR), Endovascular Stent Graft, Endograft
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- First posted
- 30 Jan 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.
An evaluation of the TALENT Aortic Cuff in patients with existing AneuRx stent grafts who have experienced sub-optimal stent graft outcomes and are not deemed suitable candidates for treatment with an AneuRx Aortic Cuff.
Detailed description
The primary purpose of this registry is to provide an endovascular means of treatment for those patients experiencing a sub-optimal outcome related to the implanted AneuRx bifurcated stent graft and who are not deemed suitable candidates for treatment with an AneuRx Aortic Cuff. A sub-optimal outcome is defined as either a Type I or Type III endoleak and/or an inadequate seal zone (< 1 cm). For Registry purposes, a Type III endoleak will be defined as a proximal modular endoleak.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient >= 18 years of age
- Patient has a serious disease or condition
- No generally acceptable alternative for treating patient is available
- Patient has had the AneuRx stent graft system implanted >= 30 days
- Patient has suboptimal outcome with the AneuRx stent graft system as evidenced by one or more of the following:
Key exclusion criteria (5 listed)
- Patient is pregnant of lactating
- Arterial access cannot be crossed with a delivery system
- Excessive vessel tortuosity
- Excessive aortic calcification
- AneuRx stent graft system implanted within the last 30 days
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 |
|---|---|---|
| TALENT Aortic Cuff Abdominal Stent GraftEndovascular Aneurysm Repair | 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 2 Nov 2021.
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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.
Medtronic CardioVascular study director
Medtronic Cardiovascular
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TALENT Aortic Cuff Abdominal Stent Graft in people with Abdominal Aortic Aneurysms, run by Medtronic Cardiovascular at 50 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 11 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 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 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 2 Nov 2021; AzTrials last refreshed its copy on 2 Nov 2026.