Abdominal Aortic AneurysmNCT01372709
TriVascular Post-Market Registry
An observational study of Abdominal Aortic Aneurysm, run by TriVascular, Inc. at 30 sites in 8 countries.
Trial summary
This is a prospective observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System ("Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). 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?
- Ovation™ or Ovation Prime™ Abdominal Stent Graft System
- Type of treatment
- Medical device
- How many people
- 501 participants
- Where
- 30 sitesin 8 countries
- Study dates
- May 2011to 14 Jun 2019
- 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: The Ovation™ or Ovation Prime™ Abdominal Stent Graft System study is a multicenter, prospective, observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms (AAA). The Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study intends to expand the clinical evidence of the safety and performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System in an all comers ("real world") patient population.
Who may be able to join
- Subject is > 18 years or minimum age as required by local regulations.
- Indication for elective repair of AAA with an endovascular stent graft in accordance with the Instructions for Use of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System.
- Subject has signed an Ethics Committee (EC) approved Informed Consent Form. The subject or legal representative has been informed of the nature of the study, has consented to participate, and has authorized the collection and release of his/her medical information.
- Subject intends to electively receive the Ovation™ or Ovation Prime™ Abdominal Stent Graft System.
- Subject has the ability and willingness to comply with all follow-up exams as indicated in clinical investigation plan.
Who cannot join
- Subject demonstrates high probability of non-adherence to physician's follow-up requirements.
- Subject's current participation in a concurrent randomized control trial (RCT) or investigational device/drug study which could confound study results.
- Life expectancy less than 1 year
- Pregnancy
- Subjects with poor renal function as indicated by a serum creatinine > 2.5mg/dl.
Trial locations and contacts
30 sites in 8 countries.
30 sites in 8 countries
Italy10 sites
Ospedale San Raffaele
Milan
Policlinico San Donato
Milan
Ospedale Civico Palermo
Palermo
Ospedale Bianchi Melacrino Morelli
Reggio Calabria
Azienda Ospedaliera Sant'Andrea
Roma
Ospedale San Giovanni Addolorata
Roma
Università La Sapienza/Policlinico Umberto I
Roma
Univeristà La Sapienza/Policlinico Umberto I
Rome
Ospedale San Giovanni Bosco
Torino
A.O. Ospedale di Circolo e Fondazione Macchi
Varese
Germany7 sites
Herz- und Gefässzentrum Bad Bevensen
Bad Bevensen
Franziskus-Krankenhaus Berlin
Berlin
Cardiovascular Center
Frankfurt
Universitäres Herz und Gefaßzentrum Hamburg
Hamburg
Städtisches klinikum Karlsruhe Klinik für Gefäß- und Thoraxchirurgie
Karlsruhe
Park Hospital Leipzig, Strümpellstr. 41
Leipzig, Western Saxony Land, 04289
"CA Gefäßchirurgie Theresienkrankenhaus/St. Hedwig"
Mannheim
Belgium5 sites
O.L. Vrouwziekenhuis
Aalst
Imelda Ziekenhuis
Bonheiden
Flanders Medical Research Program
Dendermonde
Universiteit Gent
Ghent
UZ Leuven
Leuven
United Kingdom3 sites
Frimley Park Hospital NHS Foundation Trust
Frimley
St. George's Vascular Institute
London
Manchester Royal Infirmary
Manchester
France2 sites
Groupe Hospitalier Edouard Herriot
Lyon
Hôpital Paul d'Egine
Paris
Austria1 site
Medical University of Vienna Dept. for Radiology, Section for Cardiovascular and Interventional Radiology
Vienna
About this study
Official title: A Post-Market Study to Evaluate the Safety and Performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System
This is a prospective observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System ("Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market study is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation™ or Ovation Prime™ Abdominal Stent Graft System in actual clinical practice following commercial approval.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Ovation™ or Ovation Prime™ 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™ or Ovation Prime™ Abdominal Stent Graft SystemDevice
Single occurrence permanent implant of AAA device.
| Study group | Role | What they receive |
|---|---|---|
| Ovation™ or Ovation Prime™ Abdominal Stent Graft System | Adult male and female patients will be consecutively screened for the study. Eligible patients must meet all of the inclusion criteria and none of the exclusion criteria. Receives: Device: Ovation™ or Ovation Prime™ Abdominal Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success at 12 Months Post-Implantation/surgery.
The primary endpoint is treatment success at 12 months post-implantation/surgery. Treatment success is defined as a composite technical endpoint composed of successful introduction and deployment of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System at the initial implantation procedure along with clinical endpoints of absence from type I or III endoleaks, aneurysm expansion, aneurysm rupture, conversion to open surgical repair, graft migration, and graft occlusion at 12 months post-implantation procedure.
Measured: 12 Months
Secondary outcomes (1)
Safety and Performance Endpoints
- Freedom from type I and III endoleaks [1 \& 6 m, \& annual through 5 years]
- Freedom from aneurysm rupture [6 m, \& annual through 5 years]
- Freedom from aneurysm related mortality [1 month]
- Freedom from aneurysm expansion [6 m, \& annual through 5 years]
- Freedom from stent graft migration [6 m, \& annual through 5 years]
- Freedom from loss of device patency [1 \& 6 m, \& annual through 5 years]
- Freedom from aneurysm-related secondary endovascular procedures [1 \& 6 m, \& annual through 5 years]
- Freedom from device related adverse events [1 \& 6 m, \& annual through 5 years]
Measured: 1, 6, &12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startMay 2011
- Primary completion12 Dec 2014
- Study completion14 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriVascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372709
- Sponsor's protocol ID
- 771-0008
- Status last verified
- Jun 2021
- First submitted
- 10 Jun 2011
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
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 Study to Evaluate the Safety and Performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System
- ClinicalTrials.gov ID
- NCT01372709
- Acronym / sponsor ID
- 771-0008
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- abdominal, aortic, aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- TriVascular, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011 (actual)
- Primary completion
- 12 Dec 2014 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 14 Jun 2011 (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.
This is a prospective observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System ("Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market study is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation™ or Ovation Prime™ Abdominal Stent Graft System in actual clinical practice following commercial approval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovation™ or Ovation Prime™ Abdominal Stent Graft System | – | Device: Ovation™ or Ovation Prime™ Abdominal Stent Graft SystemAdult male and female patients will be consecutively screened for the study. Eligible patients must meet all of the inclusion criteria and none of the exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Ovation™ or Ovation Prime™ Abdominal Stent Graft System study is a multicenter, prospective, observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms (AAA). The Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study intends to expand the clinical evidence of the safety and performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System in an all comers ("real world") patient population.
Key inclusion criteria (5 listed)
- Subject is > 18 years or minimum age as required by local regulations.
- Indication for elective repair of AAA with an endovascular stent graft in accordance with the Instructions for Use of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System.
- Subject has signed an Ethics Committee (EC) approved Informed Consent Form. The subject or legal representative has been informed of the nature of the study, has consented to participate, and has authorized the collection and release of his/her medical information.
- Subject intends to electively receive the Ovation™ or Ovation Prime™ Abdominal Stent Graft System.
- Subject has the ability and willingness to comply with all follow-up exams as indicated in clinical investigation plan.
Key exclusion criteria (5 listed)
- Subject demonstrates high probability of non-adherence to physician's follow-up requirements.
- Subject's current participation in a concurrent randomized control trial (RCT) or investigational device/drug study which could confound study results.
- Life expectancy less than 1 year
- Pregnancy
- Subjects with poor renal function as indicated by a serum creatinine > 2.5mg/dl.
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™ or Ovation Prime™ Abdominal Stent Graft SystemSingle occurrence permanent implant of AAA device. | Device | Ovation™ or Ovation Prime™ Abdominal Stent Graft System |
Primary outcome
Treatment Success at 12 Months Post-Implantation/surgery.
Time frame: 12 Months
The primary endpoint is treatment success at 12 months post-implantation/surgery. Treatment success is defined as a composite technical endpoint composed of successful introduction and deployment of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System at the initial implantation procedure along with clinical endpoints of absence from type I or III endoleaks, aneurysm expansion, aneurysm rupture, conversion to open surgical repair, graft migration, and graft occlusion at 12 months post-implantation procedure.
1 secondary outcome
Safety and Performance Endpoints
Time frame: 1, 6, &12 Months
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.
Related trials for Abdominal Aortic Aneurysm
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Active, not recruiting
ANEUFIX for Endoleak Type II Repair
Abdominal Aortic Aneurysm, Endoleak
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
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.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by TriVascular, Inc. at 30 sites in 8 countries.
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 5 inclusion and 5 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 30 sites in Italy, Germany, Belgium, United Kingdom, France and 3 more countries. 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?
Treatment Success at 12 Months Post-Implantation/surgery. (time frame: 12 Months). 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.