Clinical Study of the TriVascular Ovation™ Abdominal Stent Graft System

A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Ovation™ Abdominal Stent Graft System

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.

Study Overview

• Status: Completed
• Conditions: Aortic Aneurysm, Abdominal
• Intervention / Treatment: Device: Ovation™ Abdominal Stent Graft System

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Latham, New York, United States, 12110
      • Community Care Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 abdominal aortic aneurysm (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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ovation™ Abdominal Stent Graft System; Implant of Ovation™ Abdominal Stent Graft System	Device: Ovation™ Abdominal Stent Graft System; Implant of Ovation™ Abdominal Stent Graft System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Primary Safety Endpoint is Defined as the Percentage of Subjects Who Experience a Major Adverse Event Within 30 Days of the Initial Procedure.	Major adverse events (MAE) are defined as any one of the following events: Death; Myocardial Infarction; Stroke (excludes TIA); Renal Failure (excludes renal insufficiency); Respiratory Failure (excludes COPD or pulmonary complications); Paralysis (excludes paraparesis); Bowel Ischemia; Procedural Blood Loss (≥1,000 cc)	30 days
The Primary Effectiveness Endpoint is Percentage of Subjects That Achieve Treatment Success.	Treatment Success is a composite endpoint assessed at 12 months that requires the following criteria to be met: Technical Success, defined as successful delivery and deployment of one aortic body and two iliac limbs.; Freedom from Type I & III endoleaks at 12 months; Freedom from stent graft migration at 12 months; Freedom from abdominal aortic aneurysm (AAA) enlargement at 12 months; Freedom from abdominal aortic aneurysm (AAA) rupture and conversion to open repair through 12 months Endoleak Definition: Type I - Ineffective seal at either the proximal or distal sealing zones Type II - Retrograde blood flow from lumbar arteries, the inferior mesenteric artery, or other collateral vessels into the aneurysm sac Type III - A leak caused by fabric tears or disruption, component disconnection, or graft disintegration Type IV - Blood flow through an intact fabric.	1 year

Collaborators and Investigators

• Sponsor: TriVascular, Inc.
• Investigators: Principal Investigator: Manish Mehta, MD, Albany Medical College

Publications and helpful links

General Publications

• Mehta M, Valdes FE, Nolte T, Mishkel GJ, Jordan WD, Gray B, Eskandari MK, Botti C; A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Ovation Abdominal Stent Graft System Investigators. One-year outcomes from an international study of the Ovation Abdominal Stent Graft System for endovascular aneurysm repair. J Vasc Surg. 2014 Jan;59(1):65-73.e1-3. doi: 10.1016/j.jvs.2013.06.065. Epub 2013 Aug 24.

Helpful Links

• TriVascular Website
• Journal of Vascular Surgery® Publishes Results of the TriVascular Ovation™ Global Pivotal Study

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2010
• Primary Completion (Actual): December 20, 2017
• Study Completion (Actual): December 20, 2017

Study Registration Dates

• First Submitted: March 17, 2010
• First Submitted That Met QC Criteria: March 22, 2010
• First Posted (Estimate): March 24, 2010

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: aneurysm; aortic; abdominal
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 771-0006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided