TriVascular European Union (EU) Abdominal Stent Graft Trial

Abdominal Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097772
• Other study ID #: 771-0004
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: September 16, 2015

Study information

• Verified date: June 2021
• Source: Endologix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 16, 2015
• Est. primary completion date: October 29, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Ethics Committee (EC) approved Informed Consent Form

4. 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.

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 AAA device.

7. Patient has a suitable non-aneurysmal proximal aortic neck length of = 7 mm inferior to the most distal renal artery ostium.

8. 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.

9. Patient has a suitable non-aneurysmal proximal aortic neck luminal diameter between 16 and 30 mm.

10. Patient has suitable non-aneurysmal distal iliac luminal diameters between 8 and 20 mm.

11. 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.

12. Patient has juxtarenal aortic neck angulation = 60º if proximal neck is =10 mm and = 45º if proximal neck is <10 mm.

13. Patient must be willing to comply with all required follow-up exams.

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).

11. Patient has history of bleeding disorders or refuses blood transfusions.

12. Patient has dialysis dependent renal failure or baseline serum creatinine level >2.0 mg/dl

13. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.

14. Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE), PEG-based polymers or nitinol.

15. Patient has a body habitus that would inhibit X-ray visualization of the aorta

16. Patient has a limited life expectancy of less than 1 year

17. Patient is currently participating in another investigational device or drug clinical trial

18. 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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Implant of Ovation Abdominal Stent Graft System
Single occurrence permanent implant of AAA device.

Locations

Country	Name	City	State
Germany	Herz- und Gefässzentrum Bad Bevensen	Bad Bevensen
Germany	Klinikum Dortmund GmbH	Dortmund
Germany	Cardiovascular Center Frankfurt-Sankt Katherinen	Frankfurt
Germany	Universitäres Herz und Gefäß Zentrum Hamburg	Hamburg
Germany	Univeristy Klinik Köln	Köln
Germany	Herzzentrum Leipzig	Leipzig
Germany	St Franziskus Hospital Munster	Münster

Sponsors (1)

Lead Sponsor	Collaborator
TriVascular, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the performance of the TriVascular AAA Stent-Graft System within 30 days of the initial procedure.	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	30-Days

External Links

•   TriVascular Website