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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment - UniFit AAA Stent Graft | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UniFit AAA Stent Graft | Device | Endovascular repair of Abdominal Aortic Aneurysms |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 year |
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Inclusion Criteria:
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
Patient is willing and able to comply with the follow-up regime.
Patient has provided written informed consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda VA | Loma Linda | California | 92354 | United States | ||
| UCLA Medical Center |
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| Torrance |
| California |
| 90502 |
| United States |
| Christiana Hospital | Newark | Delaware | 19713 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Sacred Heart Hospital | Pensacola | Florida | 32504 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Savannah Vascular Institute | Savannah | Georgia | 31404 | United States |
| Indiana University Hospital | Indianapolis | Indiana | 46206 | United States |
| Iowa Heart Center | Des Moines | Iowa | 50266 | United States |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Englewood Hospital | Englewood | New Jersey | 07631 | United States |
| Albany Medical Center Hospital | Albany | New York | 12208 | United States |
| Dotter Interventional Institute | Portland | Oregon | 97239 | United States |
| Scott and White Hospital | Temple | Texas | 76508 | United States |
| Inova Fairfax Hospital | Fairfax | Virginia | 22042 | United States |
| Sentara Healthcare, Vascular and Transplant Specialists | Norfolk | Virginia | 23507 | United States |
| Southwest Washington Medical Center | Vancouver | Washington | 98664 | United States |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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