Aortic Aneurysm, AbdominalNCT01980901
Post-Approval Study of the Ovation™/Ovation Prime™ Abdominal Stent Graft System
An observational study of Aortic Aneurysm, Abdominal, run by TriVascular, Inc. at 1 site in United States.
Trial summary
The Post-Approval Study (PAS) will evaluate the "real world" data on the Ovation™/Ovation Prime™ Abdominal Stent Graft System along with the long-term data collected from the IDE cohort to monitor the long-term safety and effectiveness of the device. 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™/Ovation Prime™ Abdominal Stent Graft System
- Type of treatment
- Medical device
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 1 Sep 2020
- Phase
- Observational
- 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
Study population: 320 subjects enrolled with an estimated 192 evaluable subjects at the fifth year from the following cohorts: * Available data from the 161 pivotal cohort subjects * All Continued Access subjects; * All subjects from the HDE PAS (reference H100008); and * A minimum of 59 subjects from de novo enrollment.
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 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 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 Ovation/Ovation Prime 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.
- 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, 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 an 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.
United States1 site
Christie Clinical Vein and Vascular Center
Champaign, Illinois, 61820
About this study
Official title: A Post-Market Approved (PMA) Post-Approval Study to Evaluate the Long-Term Safety and Effectiveness of the Ovation™/Ovation Prime™ Abdominal Stent Graft System
The Post-Approval Study (PAS) will evaluate the "real world" data on the Ovation™/Ovation Prime™ Abdominal Stent Graft System along with the long-term data collected from the IDE cohort to monitor the long-term safety and effectiveness of the device.
Read the detailed description
The purpose of the study is to demonstrate the long term safety and effectiveness of the Ovation™/Ovation Prime™ Abdominal Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment.
The clinical objective of the study is to evaluate the long term safety and effectiveness of the Ovation™/Ovation Prime™ Abdominal Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality.
Additionally, this study will evaluate the physician training program for modifications based on IDE and post-approval experience.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- Ovation™/Ovation Prime™ Abdominal Stent Graft System
- Keywords
- AAA
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovation™/Ovation Prime™ Abdominal Stent Graft SystemDevice
Single occurence permanent implant of AAA device.
| Study group | Role | What they receive |
|---|---|---|
| Ovation™/Ovation Prime™ Abdominal Stent Graft System | Adult male and female patients. Receives: Device: Ovation™/Ovation Prime™ Abdominal Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Aneurysm-Related Mortality at 5 Years
The primary endpoint of the Ovation™/Ovation Prime™ Abdominal Stent Graft System study will be determined by evaluating freedom from aneurysm-related mortality at five (5) years. This will be compared to a target performance goal.
Measured: 5 Years
Secondary outcomes (1)
Composite Safety and Performance Endpoints
Serious Adverse Events (SAEs) within 30 days of the initial procedure and through 12 months and annually thereafter to 5 years
At 30 days and 12 months and annually thereafter to 5 years, the following rates will be reported:
- Mortality (AAA-related and all-cause)
- Device patency
- Conversion to open surgical repair
- Endoleak
- AAA enlargement
- Stent Graft Migration
- Device integrity
- Secondary endovascular procedures
- Aneurysm rupture
Measured: 1 Month & Annually 1 to 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startOct 2013
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriVascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Syed Hussain, MD, Principal investigator, Christie Clinical Vein and Vascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980901
- Sponsor's protocol ID
- 771-0010
- Status last verified
- Jun 2021
- First submitted
- 4 Nov 2013
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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 Post-Market Approved (PMA) Post-Approval Study to Evaluate the Long-Term Safety and Effectiveness of the Ovation™/Ovation Prime™ Abdominal Stent Graft System
- ClinicalTrials.gov ID
- NCT01980901
- Acronym / sponsor ID
- 771-0010
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- AAA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- TriVascular, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 11 Nov 2013 (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.
The Post-Approval Study (PAS) will evaluate the "real world" data on the Ovation™/Ovation Prime™ Abdominal Stent Graft System along with the long-term data collected from the IDE cohort to monitor the long-term safety and effectiveness of the device.
Detailed description
The purpose of the study is to demonstrate the long term safety and effectiveness of the Ovation™/Ovation Prime™ Abdominal Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment.
The clinical objective of the study is to evaluate the long term safety and effectiveness of the Ovation™/Ovation Prime™ Abdominal Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality.
Additionally, this study will evaluate the physician training program for modifications based on IDE and post-approval experience.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovation™/Ovation Prime™ Abdominal Stent Graft System | – | Device: Ovation™/Ovation Prime™ Abdominal Stent Graft SystemAdult male and female patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 320 subjects enrolled with an estimated 192 evaluable subjects at the fifth year from the following cohorts: * Available data from the 161 pivotal cohort subjects * All Continued Access subjects; * All subjects from the HDE PAS (reference H100008); and * A minimum of 59 subjects from de novo enrollment.
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 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 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 |
|---|---|---|
| Ovation™/Ovation Prime™ Abdominal Stent Graft SystemSingle occurence permanent implant of AAA device. | Device | Ovation™/Ovation Prime™ Abdominal Stent Graft System |
Primary outcome
Freedom From Aneurysm-Related Mortality at 5 Years
Time frame: 5 Years
The primary endpoint of the Ovation™/Ovation Prime™ Abdominal Stent Graft System study will be determined by evaluating freedom from aneurysm-related mortality at five (5) years. This will be compared to a target performance goal.
1 secondary outcome
Composite Safety and Performance Endpoints
Time frame: 1 Month & Annually 1 to 5 Years
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.
- 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.
Syed Hussain, MD principal investigator
Christie Clinical Vein and Vascular Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 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 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?
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?
Freedom From Aneurysm-Related Mortality at 5 Years (time frame: 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.