Clinical Study of the TriVascular Ovation™ Abdominal Stent Graft System

NCT01092117 | Completed Results DMC

• 1 other identifier: 771-0006
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Aneurysm, Abdominal

Keywords

abdominal; aortic; aneurysm

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Ovation™ Abdominal Stent Graft System

OTHER

Implant of Ovation™ Abdominal Stent Graft System

Device: Ovation™ Abdominal Stent Graft System

Interventions

Ovation™ Abdominal Stent Graft System DEVICE

Implant of Ovation™ Abdominal Stent Graft System

Ovation™ Abdominal Stent Graft System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patient is \> 18 years of age
• 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)
• Patient has signed an Institutional Review Board (IRB) approved Informed Consent Form
• 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.
• 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
• Patient has patent iliac or femoral arteries that allow endovascular access with the TriVascular Ovation Abdominal Stent Graft System.
• Patient has a suitable non-aneurysmal proximal aortic neck length of ≥ 7 mm inferior to the most distal renal artery ostium.
• 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.
• Patient has a suitable non-aneurysmal proximal aortic neck luminal diameter between 16 and 30 mm.
• Patient has suitable non-aneurysmal distal iliac luminal diameters between 8 and 20 mm.
• 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.
• Patient has juxtarenal aortic neck angulation ≤ 60º if proximal neck is ≥10 mm and ≤ 45º if proximal neck is \<10 mm.

Sponsors & Collaborators

• TriVascular, Inc.: lead

Study Sites (1)

Community Care Physicians

Latham, New York, 12110, United States

Location

Related Publications (1)

• 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.

  PMID: 23978572 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Manager, Clinical Affairs
• Organization: Endologix

nsmith@endologix.com

864-270-8524

Study Officials

• Manish Mehta, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 24, 2010
• Study Start: April 29, 2010
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: December 21, 2021
• Results First Posted: December 21, 2021

Record last verified: 2021-11

Locations

US (1)