TriVascular European Union (EU) Abdominal Stent Graft Trial

NCT01097772 | Completed DMC

• 1 other identifier: 771-0004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

Brief Summary

A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System

Conditions

Abdominal Aortic Aneurysm

Keywords

abdominal; aortic; aneurysm

Outcome Measures

Primary Outcomes (1)

• The primary safety endpoint is defined as the proportion of subjects who experience a Serious Adverse Event within 30 days of the initial procedure.

  The safety of the TriVascular AAA Stent Graft will be determined by comparing the rate of Serious Adverse Events in the Treatment Group against the rate of Serious Adverse Events in the Control Group within 30 days of the initial procedure.

  30-Days

Secondary Outcomes (1)

• To evaluate the performance of the TriVascular AAA Stent-Graft System within 30 days of the initial procedure.

  30-Days

Study Arms (1)

Ovation Abdominal Stent Graft System

OTHER

Implant of Ovation Abdominal Stent Graft System

Device: Implant of Ovation Abdominal Stent Graft System

Interventions

Implant of Ovation Abdominal Stent Graft System DEVICE

Single occurrence permanent implant of AAA device.

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 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 Ethics Committee (EC) approved Informed Consent Form
• 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; refer to Appendix III: ASA Classification System). 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 AAA device.
• 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.

You may not qualify if:

• Patient has a dissecting aneurysm
• Patient has an acutely ruptured aneurysm
• Patient has an acute vascular injury
• Patient has a need for emergent surgery
• Patient has a known thoracic aortic aneurysm or dissection.
• Patient has a mycotic aneurysm or has an active systemic infection
• 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)
• Patient has had a myocardial infarction (MI) and/or stroke (CVA) within the past 6 months.
• Patient has a major surgical or interventional procedure planned ≤30 days of the AAA repair.
• Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
• Patient has history of bleeding disorders or refuses blood transfusions.
• Patient has dialysis dependent renal failure or baseline serum creatinine level \>2.0 mg/dl
• Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
• Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE), PEG-based polymers or nitinol.
• Patient has a body habitus that would inhibit X-ray visualization of the aorta

Sponsors & Collaborators

• TriVascular, Inc.: lead

Study Sites (7)

Herz- und Gefässzentrum Bad Bevensen

Bad Bevensen, 29549, Germany

Location

Univeristy Klinik Köln

Cologne, Germany

Location

Klinikum Dortmund GmbH

Dortmund, Germany

Location

Cardiovascular Center Frankfurt-Sankt Katherinen

Frankfurt, Germany

Location

Universitäres Herz und Gefäß Zentrum Hamburg

Hamburg, Germany

Location

Herzzentrum Leipzig

Leipzig, Germany

Location

St Franziskus Hospital Munster

Münster, Germany

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

Study Officials

• Thomas Nolte, MD

  Herz- und Gefässzentrum Bad Bevensen

  PRINCIPAL INVESTIGATOR

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 31, 2010
• First Posted: April 2, 2010
• Study Start: March 1, 2010
• Primary Completion: October 29, 2010
• Study Completion: September 16, 2015
• Last Updated: June 4, 2021

Record last verified: 2021-06

Locations

DE (7)