Clinical trial NCT00604643: Talent Aortic Cuff Stent Graft System Compassionate Use Registry
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
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Abdominal Aortic Aneurysms
Keywords: Abdominal Aneurysm
Endovascular Aortic Repair (EVAR)
Endovascular Stent Graft
Endograft
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2008-01-30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Baptist Hospital
state: Alabama
city: Oakland
country: United States
facility: Kaiser
state: California
city: San Jose
country: United States
facility: O'Connor Hospital
state: California
city: Union City
country: United States
facility: Kaiser Hayward
state: California
city: Colorado Springs
country: United States
facility: Penrose Healthcare
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital
state: District of Columbia
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Gainesville
country: United States
facility: North Florida Regional Medical Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Tampa
country: United States
facility: JA Haley Veterans Hospital
state: Florida
city: Atlanta
country: United States
facility: St. Joseph's Hospital
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Hospital
state: Georgia
city: La Grange
country: United States
facility: LaGrange Memorial Hospital
state: Illinois
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Wichita
country: United States
facility: Via Christi Regional Medical center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky medical Center
state: Kentucky
city: Louisville
country: United States
facility: Baptist Hospital
state: Kentucky
city: Lafayette
country: United States
facility: Southwest Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Saint Clair Shores
country: United States
facility: Bon Secours Cottage Health Center
state: Michigan
city: Saint Joseph
country: United States
facility: Lakeland Regional Medical Center
state: Michigan
city: Saint Cloud
country: United States
facility: St. Cloud Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: Health Easst St. Joseph's Hospital
state: Minnesota
city: Jackson
country: United States
facility: CV Surgical Clinic
state: Mississippi
city: Jackson
country: United States
facility: St. Dominic-Jackson
state: Mississippi
city: Meridian
country: United States
facility: Jeff Anderson Regional Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock
state: New Hampshire
city: Albuquerque
country: United States
facility: NMVA Healthcare
state: New Mexico
city: Utica
country: United States
facility: St. Luke's Healthcare
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Charlotte
country: United States
facility: The Sanger Clinic-Carolinas Medical
state: North Carolina
city: Clackamas
country: United States
facility: Kaiser Sunnyside
state: Oregon
city: Harrisburg
country: United States
facility: Pinnacle Health Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hahnemann Univeristy Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Graduate Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: Providence Hospital
state: South Carolina
city: West Columbia
country: United States
facility: Lexington Medical Center
state: South Carolina
city: Sioux Falls
country: United States
facility: North Central heart Institute
state: South Dakota
city: Harlingen
country: United States
facility: Harlingen Medical Center
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Houston
country: United States
facility: Houston Northwest Medical Center
state: Texas
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Richmond
country: United States
facility: Henrico Doctors' Hospital
state: Virginia
city: Milwaukee
country: United States
facility: St. Luke's medical Center
state: Wisconsin
Study officials:
affiliation: Medtronic Cardiovascular
name: Medtronic CardioVascular
role: STUDY_DIRECTOR
References: