TriVascular European Union (EU) Abdominal Stent Graft Trial
This study has been completed.
Information provided by (Responsible Party):
First received: March 31, 2010
Last updated: November 4, 2015
Last verified: November 2015
A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System
Abdominal Aortic Aneurysm
Device: Implant of Ovation Abdominal Stent Graft System
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation™ Abdominal Stent Graft System
Primary Outcome Measures:
Secondary Outcome Measures:
- To evaluate the performance of the TriVascular AAA Stent-Graft System within 30 days of the initial procedure. [ Time Frame: 30-Days ] [ Designated as safety issue: Yes ]
The performance of the TriVascular AAA Stent-Graft System will be determined by comparing the composite success rate in the Treatment Group against an estimated success rate of 80% in the Control Group within 30 days of the initial procedure. The composite success rate is defined as:
- Technical Success, defined as successful delivery and deployment of one aortic body and two iliac limbs.
- Absence of Type I and III endoleaks
- Absence of Rupture
- Absence of Conversion to Open Surgical Repair
- Freedom from mortality
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2010 (Final data collection date for primary outcome measure)
Ovation Abdominal Stent Graft System
Implant of Ovation Abdominal Stent Graft System
Device: Implant of Ovation Abdominal Stent Graft System
Single occurrence permanent implant of AAA device.
A prospective, consecutively enrolling, non-randomized multi center clinical evaluation of the safety and performance of the TriVascular AAA Stent Graft when used in the treatment of patients with Abdominal Aortic Aneurysms (AAA).
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- Patient must be willing to comply with all required follow-up exams.
- 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
- Patient has a limited life expectancy of less than 1 year
- Patient is currently participating in another investigational device or drug clinical trial
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01097772
|Herz- und Gefässzentrum Bad Bevensen
|Bad Bevensen, Germany, 29549 |
||Thomas Nolte, MD
||Herz- und Gefässzentrum Bad Bevensen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 31, 2010
||November 4, 2015
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by TriVascular, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on January 17, 2017
Aortic Aneurysm, Abdominal