TriVascular European Union (EU) Abdominal Stent Graft Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
TriVascular, Inc.
ClinicalTrials.gov Identifier:
NCT01097772
First received: March 31, 2010
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

A prospective, consecutively enrolling, non-randomized multi center clinical evaluation of the safety and performance of the TriVascular AAA Stent Graft when used in the treatment of patients with Abdominal Aortic Aneurysms (AAA).


Condition Intervention Phase
Abdominal Aortic Aneurysm
Device: Implant of Ovation Abdominal Stent Graft System
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System

Resource links provided by NLM:


Further study details as provided by TriVascular, Inc.:

Primary Outcome Measures:
  • The primary safety endpoint is defined as the proportion of subjects who experience a Serious Adverse Event within 30 days of the initial procedure. [ Time Frame: 30-Days ] [ Designated as safety issue: Yes ]
    The safety of the TriVascular AAA Stent Graft will be determined by comparing the rate of Serious Adverse Events in the Treatment Group against the rate of Serious Adverse Events in the Control Group within 30 days of the initial procedure.


Secondary Outcome Measures:
  • To evaluate the performance of the TriVascular AAA Stent-Graft System within 30 days of the initial procedure. [ Time Frame: 30-Days ] [ Designated as safety issue: Yes ]

    The performance of the TriVascular AAA Stent-Graft System will be determined by comparing the composite success rate in the Treatment Group against an estimated success rate of 80% in the Control Group within 30 days of the initial procedure. The composite success rate is defined as:

    1. Technical Success, defined as successful delivery and deployment of one aortic body and two iliac limbs.
    2. Absence of Type I and III endoleaks
    3. Absence of Rupture
    4. Absence of Conversion to Open Surgical Repair
    5. Freedom from mortality


Enrollment: 30
Study Start Date: March 2010
Estimated Study Completion Date: September 2015
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Implant of Ovation Abdominal Stent Graft System
    Single occurrence permanent implant of AAA device.
  Eligibility

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

Inclusion Criteria:

  1. Patient is > 18 years of age
  2. Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
  3. Patient has signed an Ethics Committee (EC) approved Informed Consent Form
  4. Patient is considered by the treating physician to be a candidate for elective open surgical repair of the AAA (i.e., category I, II, or III per American Society of Anesthesiology (ASA) classification; refer to Appendix III: ASA Classification System). ASA category IV patients may be enrolled provided their life expectancy is greater than 1 year.
  5. Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following:

    • Abdominal aortic aneurysm ≥5.0 cm in diameter
    • Aneurysm has increased in size by 0.5 cm in last 6 months.
    • Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment
  6. Patient has patent iliac or femoral arteries that allow endovascular access with the TriVascular AAA device.
  7. Patient has a suitable non-aneurysmal proximal aortic neck length of ≥ 7 mm inferior to the most distal renal artery ostium.
  8. Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥10 mm. The resultant repair should preserve patency in at least one hypogastric artery.
  9. Patient has a suitable non-aneurysmal proximal aortic neck luminal diameter between 16 and 30 mm.
  10. Patient has suitable non-aneurysmal distal iliac luminal diameters between 8 and 20 mm.
  11. Patient meets the following anatomic criteria: the distance from the most distal renal artery to most superior internal iliac artery measurement is at least 13 cm.
  12. Patient has juxtarenal aortic neck angulation ≤ 60º if proximal neck is ≥10 mm and ≤ 45º if proximal neck is <10 mm.
  13. Patient must be willing to comply with all required follow-up exams.

Exclusion Criteria:

  1. Patient has a dissecting aneurysm
  2. Patient has an acutely ruptured aneurysm
  3. Patient has an acute vascular injury
  4. Patient has a need for emergent surgery
  5. Patient has a known thoracic aortic aneurysm or dissection.
  6. Patient has a mycotic aneurysm or has an active systemic infection
  7. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
  8. Patient has had a myocardial infarction (MI) and/or stroke (CVA) within the past 6 months.
  9. Patient has a major surgical or interventional procedure planned ≤30 days of the AAA repair.
  10. Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
  11. Patient has history of bleeding disorders or refuses blood transfusions.
  12. Patient has dialysis dependent renal failure or baseline serum creatinine level >2.0 mg/dl
  13. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
  14. Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE), PEG-based polymers or nitinol.
  15. Patient has a body habitus that would inhibit X-ray visualization of the aorta
  16. Patient has a limited life expectancy of less than 1 year
  17. Patient is currently participating in another investigational device or drug clinical trial
  18. Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
  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: NCT01097772

Locations
Germany
Herz- und Gefässzentrum Bad Bevensen
Bad Bevensen, Germany, 29549
Sponsors and Collaborators
TriVascular, Inc.
Investigators
Principal Investigator: Thomas Nolte, MD Herz- und Gefässzentrum Bad Bevensen
  More Information

Additional Information:
No publications provided by TriVascular, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: TriVascular, Inc.
ClinicalTrials.gov Identifier: NCT01097772     History of Changes
Other Study ID Numbers: 771-0004
Study First Received: March 31, 2010
Last Updated: November 8, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by TriVascular, Inc.:
abdominal
aortic
aneurysm

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

ClinicalTrials.gov processed this record on September 15, 2014