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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00705718
First received: June 24, 2008
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Abdominal Aortic Aneurysms
Device: Endurant Stent Graft System
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endurant Stent Graft System US Clinical Study

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure) [ Time Frame: 30 days (Safety) ] [ Designated as safety issue: Yes ]

    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

  • Major Adverse Events Within 30 Days of Index Procedure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    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

  • Primary Effectiveness Endpoint (Technical Success) [ Time Frame: Intra-operatively ] [ Designated as safety issue: No ]
    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.

  • Primary Effectiveness Endpoint (Treatment Success) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Secondary Endpoints - Safety Evaluation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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)

  • Secondary Endpoint - Effectiveness Evaluation [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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


Enrollment: 194
Study Start Date: June 2008
Estimated Study Completion Date: November 2016
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endurant Bifurcated arm Device: Endurant Stent Graft System
Abdominal Aortic Aneurysm Repair
Other Name: Endovascular treatment of Abdominal Aortic Aneurysm
Experimental: Endurant AUI arm Device: Endurant Stent Graft System
Abdominal Aortic Aneurysm Repair
Other Name: Endovascular treatment of Abdominal Aortic Aneurysm

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705718

  Show 30 Study Locations
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Michel S Makaroun, MD Division of Vascular Surgery University of Pittsburgh Medical Center
  More Information

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00705718     History of Changes
Other Study ID Numbers: Medtronic - 089
Study First Received: June 24, 2008
Results First Received: January 31, 2014
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:
Endurant Stent Graft System, endovascular treatment, Abdominal Aortic Aneurysms

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on August 28, 2014