Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System

Abdominal Aortic Aneurysms Clinical Trial

Official title:

Endurant Stent Graft System US Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705718
• Other study ID #: Medtronic - 089
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Est. completion date: September 26, 2016

Study information

• Verified date: October 2021
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.

Description:

Prospective, two-arm, non-randomized, multicenter clinical study enrolling subjects treated with the bifurcated stent graft in one arm and subjects treated with the AUI in a second arm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: September 26, 2016
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is = 18 years old.

2. Subject (or Subject's legal representative) understands and voluntarily has signed and dated an Informed Consent document approved by the Sponsor and by the Institutional Review Board.

3. Subject is able and willing to comply with the protocol and undergo follow-up requirements.

4. Subject is a suitable candidate for elective surgical repair of AAA by as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, III, or IV

5. Subject has an abdominal aortic or aortoiliac aneurysm characteristics that meet protocol parameter

6. Subject meets all the protocol anatomical criteria* as demonstrated on contrast-enhanced CT or MRA

7. Subject has vascular dimensions in the range of sizes available for the Endurant Stent Graft

8. Subject has documented imaging evidence of at least 1 patent iliac and 1 femoral artery, or can tolerate a vascular conduit that allows introduction of the device.

9. Subject's native vessel anatomy is more suited for the introduction and/ or deployment of an Endurant Uni-Iliac Stent Graft System.

Exclusion Criteria:

1. Subject has a life expectancy < 1 year

2. Subject is participating in another investigational drug or device study

3. Subject requires emergent aneurysm treatment

4. Subject is a female of childbearing potential in whom pregnancy cannot be excluded.

5. Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.

6. Subject is morbidly obese (body mass index = 40 kg/m2) or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysms
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Endurant Stent Graft System
Abdominal Aortic Aneurysm Repair

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	Mission Hospitals	Asheville	North Carolina
United States	Emory University Hospital	Atlanta	Georgia
United States	University of Alabama Hospitals	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Sisters of Charity Hospital	Buffalo	New York
United States	Mid Carolina Presbyterian Hospital	Charlotte	North Carolina
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Lindner Clinical Trial Center	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Iowa Methodist Medical Center	Des Moines	Iowa
United States	Good Samaritan Hospital	Downers Grove	Illinois
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Wellstar Kennestone Hospital	Marietta	Georgia
United States	Baptist Memorial Hospital Memphis	Memphis	Tennessee
United States	Mount Sinai School of Medicine	New York	New York
United States	NYU Hospitals Center	New York	New York
United States	University of Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Arizona Heart Institute	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Premier Surgical Associates	Powell	Tennessee
United States	St. John's Mercy Medical Center	Saint Louis	Missouri
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Harborview Medical Center	Seattle	Washington
United States	Sanford Research	Sioux Falls	South Dakota
United States	Stanford University Medical Center	Stanford	California
United States	Scott & White Memorial Medical Center	Temple	Texas
United States	Jobst Vascular Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)	The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events.; All-Cause Mortality; Bowel Ischemia; Myocardial Infarction; Paraplegia; Procedural Blood Loss > or equal to 1000 cc; Renal Failure; Respiratory Failure; Stroke	30 days (Safety)
Primary	Major Adverse Events Within 30 Days of Index Procedure	The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events.; All-Cause Mortality; Bowel Ischemia; Myocardial Infarction; Paraplegia; Procedural Blood Loss > or equal to 1000 cc; Renal Failure; Respiratory Failure; Stroke	30 days
Primary	Primary Effectiveness Endpoint (Technical Success)	Technical success defined as successful delivery and deployment of the stent graft in the planned location and with no unintentional coverage of both the internal iliac arteries or any visceral aortic branches and with removal of the system. Technical success was assessed intra-operatively.	Intra-operatively
Primary	Primary Effectiveness Endpoint (Treatment Success)	Treatment success is defined as Technical success and the following: Freedom from AAA diameter increased, defined as >5 mm increase in maximum diameter as measured on CT scan (or MRA/MRI) at 12 months as compared to 1 month; Freedom from Types I and III endoleaks at 12 months including those requiring intervention through 12 months; Freedom from aneurysm rupture through 12 months; Freedom from conversion to surgery through 12 months; Freedom from stent graft migrations resulting in a serious adverse event or requiring secondary intervention through 12 months; Freedom from stent graft occlusion at 12 months	12 months
Secondary	Secondary Endpoints - Safety Evaluation	The following secondary endpoints were included in the Pivotal trial to evaluate the safety profile of the Endurant Stent Graft System.; Aneurysm-Related Mortality through 12 months; All-Cause Mortality with 30 days; All-Cause Mortality within 12 months; Major Adverse Events through 12 months; Adverse Events through 12 months; Unanticipated Adverse Device Events; Serious Adverse Events (SAEs) As reported at the time of the data cut off.; Device Related Adverse Events; Procedure Related Adverse Events; Adverse Events (excluding SAEs)	12 months
Secondary	Secondary Endpoint - Effectiveness Evaluation	The following secondary endpoints were included in the pivotal trial to evaluate the effectiveness profile of the Endurant Stent Graft System.; Stent Graft migration through 12 months; Stent Graft Patency through 12 months; All stent Graft Endoleaks at 1-month, 6-months, and 12-month; Secondary Procedures to correct Type I and type III Endoleaks through 12 months; Secondary Endovascular Procedures through 12 months; Technical Observations through 12 months	12 months