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Clinical Study of the TriVascular Ovation™ Abdominal Stent Graft System | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT01092117•TriVascular, Inc.

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 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.
+6 more criteria

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).
+8 more criteria

Locations (1)

Community Care Physicians

Latham, New York, United States

Key Dates

Start Date

April 29, 2010

Primary Completion Date

December 20, 2017

Completion Date

December 20, 2017

Last Updated

December 21, 2021

Enrollment

161

ACTUAL participants

Conditions

Aortic Aneurysm, Abdominal

Interventions

Ovation™ Abdominal Stent Graft System

DEVICE

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

NCT04503395

Aortic Aneurysm, Abdominal

View study

RECRUITING

QoL After Complex Endovascular Aortic Repair

NCT05774938

Quality of LifeAortic Aneurysm+1 more

View study

ENROLLING_BY_INVITATIONNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 21, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Study of the TriVascular Ovation™ Abdominal Stent Graft System

Inclusion Criteria

Exclusion Criteria

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

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