Overview

This trial is active, not recruiting.

Condition aortic aneurysm, abdominal
Treatment ovation™ abdominal stent graft system
Phase phase 3
Sponsor TriVascular, Inc.
Start date March 2010
End date October 2017
Trial size 150 participants
Trial identifier NCT01092117, 771-0006

Summary

The primary objectives of this study are to determine whether the Ovation Abdominal Stent Graft System is a safe and effective method of treating abdominal aortic aneurysms (AAA's) in those patients considered to be suitable candidates for open surgical repair.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Implant of Ovation™ Abdominal Stent Graft System
ovation™ abdominal stent graft system
Implant of Ovation™ Abdominal Stent Graft System

Primary Outcomes

Measure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event within 30 days of the initial procedure. The primary effectiveness endpoint is proportion of subjects that achieve Treatment Success.
time frame: 1 Year

Secondary Outcomes

Measure
Composite Safety and Effectiveness Endpoints
time frame: 1 Year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion/Exclusion Criteria: Inclusion Criteria All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study: 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 Institutional Review Board (IRB) 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. 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 Ovation Abdominal Stent Graft System. 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 Patients that meet ANY of the following are not eligible for enrollment into the study: 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, fluorinated ethylene propylene (FEP) 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.

Additional Information

Official title A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Ovation™ Abdominal Stent Graft System
Principal investigator Manish Mehta, MD
Description This is a Phase II prospective, consecutive enrolling, non-randomized multi-center clinical evaluation of the safety and effectiveness of the Ovation Abdominal Stent Graft System when used in the treatment of patients with AAA (Treatment Group) as compared to a performance goal (Control Group). 150 study patients will be enrolled at up to 40 institutions. An additional 100 study patients will be enrolled in the continued access phase.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by TriVascular, Inc..