Abdominal Aortic AneurysmNCT01097772
TriVascular European Union (EU) Abdominal Stent Graft Trial
A study testing Implant of Ovation Abdominal Stent Graft System in people with Abdominal Aortic Aneurysm, run by TriVascular, Inc. at 7 sites in Germany.
Trial summary
A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Implant of Ovation Abdominal Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesGermany
- Study dates
- Mar 2010to 16 Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Herz- und Gefässzentrum Bad Bevensen
Bad Bevensen, 29549
Univeristy Klinik Köln
Cologne
Klinikum Dortmund GmbH
Dortmund
Cardiovascular Center Frankfurt-Sankt Katherinen
Frankfurt
Universitäres Herz und Gefäß Zentrum Hamburg
Hamburg
Herzzentrum Leipzig
Leipzig
St Franziskus Hospital Munster
Münster
About this study
Official title: A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation™ Abdominal Stent Graft System
A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System
Read the detailed 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).
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Implant of Ovation Abdominal Stent Graft System
- Keywords
- abdominal, aortic, aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant of Ovation Abdominal Stent Graft SystemDevice
Single occurrence permanent implant of AAA device.
| Study group | Role | What they receive |
|---|---|---|
| Ovation Abdominal Stent Graft System | Other | Implant of Ovation Abdominal Stent Graft System Receives: Device: Implant of Ovation Abdominal Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30-Days
Secondary outcomes (1)
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
Measured: 30-Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startMar 2010
- Primary completion29 Oct 2010
- Study completion16 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriVascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Nolte, MD, Principal investigator, Herz- und Gefässzentrum Bad Bevensen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097772
- Sponsor's protocol ID
- 771-0004
- Status last verified
- Jun 2021
- First submitted
- 31 Mar 2010
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23978572
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation™ Abdominal Stent Graft System
- ClinicalTrials.gov ID
- NCT01097772
- Acronym / sponsor ID
- 771-0004
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- abdominal, aortic, aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- TriVascular, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010 (actual)
- Primary completion
- 29 Oct 2010 (actual)
- Study completion
- 16 Sep 2015 (actual)
- First posted
- 2 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovation Abdominal Stent Graft System | Other | Device: Implant of Ovation Abdominal Stent Graft SystemImplant of Ovation Abdominal Stent Graft System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant of Ovation Abdominal Stent Graft SystemSingle occurrence permanent implant of AAA device. | Device | Ovation Abdominal Stent Graft System |
Primary outcome
The primary safety endpoint is defined as the proportion of subjects who experience a Serious Adverse Event within 30 days of the initial procedure.
Time frame: 30-Days
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.
1 secondary outcome
To evaluate the performance of the TriVascular AAA Stent-Graft System within 30 days of the initial procedure.
Time frame: 30-Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Derived from this study: PubMed 23978572Mehta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Nolte, MD principal investigator
Herz- und Gefässzentrum Bad Bevensen
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant of Ovation Abdominal Stent Graft System in people with Abdominal Aortic Aneurysm, run by TriVascular, Inc. at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary safety endpoint is defined as the proportion of subjects who experience a Serious Adverse Event within 30 days of the initial procedure. (time frame: 30-Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01097772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.