Compelling Clinical Evidence

The Ovation® platform is approved to treat the widest range of patient anatomies with an innovative, less invasive, clinically proven solution. Through ongoing studies, TriVascular is committed to clinical research and providing evidence to significantly expand EVAR to more patients. Download the 2014 Ovation and Ovation Prime Clinical Summary here.

Global Pivotal Trial

Global Ovation Pivotal Trial Experience1

The Ovation® Pivotal Trial enrolled 161 patients across 36 sites and three countries. At four years, the safety and performance metrics are strong across a broad range of patients, especially considering the clinical complexity of the patient cohort.

Expanding EVAR Safely

Within the Ovation Pivotal trial, approximately 40% of patients (66/161) treated had access vessels <6mm in diameter, aortic neck length <10mm in length, or both. Patients within this anatomically challenging cohort had a 0% MAE rate at 0–30 days and a 3.0% MAE rate at 31–365 days.

The Ovation System Protects the Neck

The sealing ring technology exerts no chronic outward force and insulates the neck from blood pressure. Patients treated with the Ovation System in the pivotal study had stable neck diameters and no late Type 1 endoleaks at 4 years.5
See chart above.

 

1. Data as of July 31, 2015.
2. Technical Success based on investigator reports
3. Major Adverse Events and Device Related Major Adverse Events based on Clinical Events Committee (CEC) adjudicated data. Rupture and Conversion to Open Repair based on investigator reports.
4. Endoleaks and Migration rates based on Core Lab Data (M2S).
5. Neck dilatation in proximal neck defined as growth > 3mm at 10mm below renals, 13mm below renals, and 15mm below renals; measurement methodology in Ovation Pivotal Trial similar to measurement methodology in cited studies.
6. Monahan JVS 2010: 52: 303-7 N=46. Devices: Cook Zenith.
7. Rodway Eur J Endovasc Surg 2008; 35: 685-93 EVAR: N=67, Open: N=56. Data available for up to 2 years.

Anatomically Challenging Cohort

Technical Success2                                                                      

All
N=161

Defined as successful delivery and deloyment of one aortic body and two iliac limbs

100%

Safety3

0-30
Days

31-365
Days

366-730
Days

731-1095
Days

1096-1460
Days

Major Adverse Events

2.5%

3.8%

--

--

--

Device Related Major Adverse Events

0.0%

0.0%

--

--

--

Rupture

0.0%

0.0%

0.0%

0.0%

0.0%

Conversion to Open Repair

0.0%

0.0%

0.0%

0.0%

0.0%

Effectiveness4

30 Days

1 Year

2 Years

3 Years

4 Years

Type I/III endoleaks

0%

0%

0%

0%

0%

Migration

Baseline

0%

0%

0%

0%

Post-Market Registry

OVATION, a multicenter, prospective postmarket study, is continuing the evaluation of the safety and performance of the Ovation® and Ovation Prime Abdominal Stent Graft Systems. 501 patients were enrolled across 30 sites in Europe from 2011-2013. OVATION has reported encouraging results in the real-world setting of routine clinical practice.

1. Limb Occlusions defined as re-interventions due to limb occlusion.
2. Ns represent the number of completed follow-up visits for 1m, 6m, 1yr, and 2yr.

Technical Success                                                            

All

Successful delivery and deployment of one aortic body and two iliac limbs

99.6%
(499/501)

Safety

0 to 30
Days

31 to 365
Days

366 to 730
Days

Rupture

0.2%
(1/501)

0.0%
(0/499)

0.0%
(0/472)

Conversion to Open Repair

0.0%
(0/501)

0.2%
(1/499)

0.4%
(2/472)

Iliac Occlusions1

1.2%
(6/501)

1.2%
(6/499)

0.0%
(0/472)

Performance 2

30 Days

1 Year

2 Year

Type I and III Endoleaks

1.1%
(5/454)

1.6%
(6/384)

0.5%
(1/196)

Migration

0.0%
(0/440)

0.3%
(1/378)

0.0%
(0/195)

The Life Study

STUDY DESCRIPTION

The LIFE Study is a prospective, consecutively enrolling, non-randomized multi center post-market registry to evaluate the ultra low profile (14F) Ovation Prime® Abdominal Stent Graft Platform when used in the Percutaneous Endovascular Aneurysm Repair (P-EVAR) treatment of patients with AAA using a Fast-Track EVAR protocol.

STUDY OBJECTIVES

The primary objectives of the LIFE Study are to demonstrate the clinical and cost benefits associated with using the Ovation Prime Abdominal Stent Graft Platform under the least invasive conditions defined in the Fast-Track EVAR protocol. The key elements of the Fast-Track EVAR protocol include:

  • Appropriate patient selection (i.e., candidate for Ovation Prime device, Inclusion/Exclusion criteria)
  • Bilateral percutaneous access
  • No general anesthesia (e.g., local or conscience sedation)
  • No ICU admission post procedure
  • Next day discharge (one midnight stay)

 

More information about The LIFE Study can be found here.

The Lucy Study

TriVascular Evaluation of FemaLes
who are Underrepresented Candidates for
Abdominal Aortic AneurYsm Repair

STUDY RATIONALE

Women are under-represented in EVAR clinical trials which prevents the generalization of clinical findings to the broader female population with AAA requiring intervention. Consequently there is a lack of information for these patients and their physicians regarding risks and benefits of EVAR. The TriVascular Ovation® platform can accommodate small diameter access vessels and challenging aortic necks, suggesting this endograft may be particularly well-suited to the study of EVAR in women.

STUDY DESCRIPTION

The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center post-market registry to evaluate the ultra low profile (14F) Ovation Platform when used in the endovascular treatment of AAA in female patients.

STUDY DESIGN

Study will enroll up to 225 subjects (75 females in the Treatment Group and 150 males in the Control Group) in up to 45 sites in the U.S. Study results will provide a comparison of female and male patient outcomes.

More information about The LUCY Study can be found here.