Aortic Aneurysm, AbdominalNCT01092117
Clinical Study of the TriVascular Ovation™ Abdominal Stent Graft System
A study testing Ovation™ Abdominal Stent Graft System in people with Aortic Aneurysm, Abdominal, run by TriVascular, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- Ovation™ Abdominal Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2010to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:
- 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:
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- 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.
- Patient must be willing to comply with all required follow-up exams.
Who cannot join
- Patients that meet ANY of the following are not eligible for enrollment into the study:
- 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.
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- 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, fluorinated ethylene propylene (FEP) 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
1 site in 1 country.
About this study
Official title: A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Ovation™ Abdominal Stent Graft System
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.
Read the detailed description
This is a Phase II prospective, consecutive enrolling, non-randomized multi-center clinical evaluation of the safety and effectiveness of the Ovation Abdominal Stent Graft System when used in the treatment of patients with AAA (Treatment Group) as compared to a performance goal (Control Group).
150 study patients will be enrolled at up to 40 institutions. An additional 100 study patients will be enrolled in the continued access phase.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- 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.
Ovation™ Abdominal Stent Graft SystemDevice
Implant of Ovation™ Abdominal Stent Graft System
| Study group | Role | What they receive |
|---|---|---|
| Ovation™ Abdominal Stent Graft System | Other | Implant of Ovation™ Abdominal Stent Graft System Receives: Device: 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 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)
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study start29 Apr 2010
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm, AbdominalStudies 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
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriVascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manish Mehta, MD, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092117
- Sponsor's protocol ID
- 771-0006
- Status last verified
- Nov 2021
- First submitted
- 17 Mar 2010
- Last updated
- 21 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Ovation™ Abdominal Stent Graft System
- ClinicalTrials.gov ID
- NCT01092117
- Acronym / sponsor ID
- 771-0006
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- abdominal, aortic, aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- TriVascular, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2010 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Posted 21 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase II prospective, consecutive enrolling, non-randomized multi-center clinical evaluation of the safety and effectiveness of the Ovation Abdominal Stent Graft System when used in the treatment of patients with AAA (Treatment Group) as compared to a performance goal (Control Group).
150 study patients will be enrolled at up to 40 institutions. An additional 100 study patients will be enrolled in the continued access phase.
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: 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 (17 listed)
- All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:
- 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.
Key exclusion criteria (19 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 |
|---|---|---|
| Ovation™ Abdominal Stent Graft SystemImplant of Ovation™ Abdominal Stent Graft System | Device | Ovation™ Abdominal Stent Graft System |
Primary outcome
The Primary Safety Endpoint is Defined as the Percentage of Subjects Who Experience a Major Adverse Event Within 30 Days of the Initial Procedure.
Time frame: 30 days
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)
The Primary Effectiveness Endpoint is Percentage of Subjects That Achieve Treatment Success.
Time frame: 1 year
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
Manish Mehta, MD principal investigator
Albany Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovation™ Abdominal Stent Graft System in people with Aortic Aneurysm, Abdominal, run by TriVascular, Inc. at 1 site in United States.
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 17 inclusion and 19 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 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 21 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Percentage of Subjects Who Experience a Major Adverse Event Within 30 Days of the Initial Procedure. (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT01092117, 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 21 Dec 2021.