Aortic Aneurysm, AbdominalNCT01276249
The STAPLE International Post-Market Registry
An observational study of Aortic Aneurysm, Abdominal and Aorto Iliac Aneurysm, run by Medtronic Cardiovascular at 9 sites in 6 countries.
Trial summary
The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal, Aorto Iliac Aneurysm
- What is being tested?
- Fortevo Endograft
- Type of treatment
- Medical device
- How many people
- 108 participants
- Where
- 9 sitesin 6 countries
- Study dates
- Aug 2010to 19 Jun 2015
- 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: Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair.
Who may be able to join
- Patient ≥ 18 years old
- Patient has given written informed consent
- Patient has a life expectancy > 1 year
- Patient is willing to comply with follow-up evaluations
- Patient's AAA meets at least one of the following criteria:
- ≥ 4.5cm in diameter
Show all 13Show fewer
- Increased in size by 0.5cm in last 6 months
- Maximum diameter exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment
- Saccular aneurysm larger than 3cm in maximal diameter
- Patient has a proximal aortic neck diameter measured inner wall to inner wall between 19mm and 29mm
- Patient has a proximal aortic neck length of at least 12mm
- Patient has a patent iliac or femoral artery that allows endovascular access to the aneurysmal site with 16Fr (5.3mm) or 18Fr (6.0mm) delivery system.
- Patient has bilateral iliac artery distal fixation site ≥ 10mm in length with an internal diameter between 9mm and 20mm
Who cannot join
- Patient is participating in a concurrent clinical study which may confound STAPLE-International Registry results
- Patient has a symptomatic AAA
- Patient's AAA has a proximal aortic neck angle that is > 60 degrees between the infrarenal neck and the long axis of the aneurysm
- Patient has irregularly-shaped plaque that would inhibit sealing stent apposition
- Patient has aortic mural pathology that is ≥ 2mm in thickness over ≥ 50% of the circumference of the proximal fixation site
- Patient has an active, or known history of, bleeding diathesis or hypercoagulable condition
- Patient has a contraindication to any materials to which he or she will be exposed during the EVAR procedure (i.e., Fortevo Endograft or Heli-FX EndoAnchor System materials, contrast agents)
- Patient has a genetic connective tissue disorder (e.g., Marfan's or Ehlers-Danloe Syndromes)
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
Germany3 sites
German Heart Center
Berlin
Cardiovascular Center Frankfurt
Frankfurt
St. Bonifatious Hospital
Lingen
Spain2 sites
Thorax Institute Hospital Clinic
Barcelona
University of Navarra
Pamplona
About this study
Official title: The STAPLE-International Post-Market Registry
The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.
Read the detailed description
The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.
All subjects diagnosed with a qualifying AAA suitable for elective endovascular repair, who meet the inclusion/exclusion criteria for the registry, are eligible for enrollment and should be offered informed consent to participate.
- Conditions
- Aortic Aneurysm, Abdominal, Aorto Iliac Aneurysm
- Being tested
- Fortevo Endograft
- Keywords
- Aptus Endosystem, EndoStaple, Endograft, Stent Graft, Abdominal Aortic Aneurysm, Heli-FX, EndoAnchor
- 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.
Fortevo EndograftDevice
The Fortevo Endograft, Main Body and Iliac Lumen Delivery System are indicated for the endovascular treatments of patients with infrarenal abdominal aortic aneurysms or aortic-iliac aneurysms having suitable morphology for endovascular repair.
| Study group | Role | What they receive |
|---|---|---|
| Fortevo Endograft | All subjects diagnosed with a qualifying AAA suitable for elective endovascular repair, who meet the inclusion/exclusion criteria for the registry, are eligible for enrollment if treated with the Fortevo Endograft. Receives: Device: Fortevo Endograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
The first primary endpoint is primary technical success. It consists of the following items:
- Successful arterial access
- Successful deployment of the Fortevo Endograft with secure proximal and distal fixation
- Absence of type I or III endoleaks
- Patent Fortevo Endograft without significant twist, kinking, or obstruction
Measured: Within 24 hours of the Index procedure
Major Adverse Events (MAE)
The second primary endpoint is associated with the safety profile of the device, and is defined as the percent of patients experiencing one or more of major adverse events (MAE) within one month of implantation. 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)
Measured: Within 1-Month of Implantation
Secondary outcomes (1)
Clinical Success and Safety of the Fortevo Endograft and Heli-FX EndoAnchor System components
Clinical Success is defined as Successful Deployment of the Fortevo Endograft at the intended location and the absence of:
- Death as a result of aneurysm-related treatment
- Type I or III endoleak
- Fortevo Endograft infection
- Fortevo Endograft thrombosis
- Fortevo Endograft dilatation by 20% or more in diameter
- Fortevo Endograft migration by 10mm or more at the proximal neck at 6-M and 12-M
- Loss of Fortevo Endograft or Heli-FX EndoAnchor System integrity
- Aneurysm expansion by 5mm (or more) in maximal diameter at 6-M and 12-M
- Aneurysm rupture
- Conversion to open repair
Measured: 1-Month, 6-Months and 12-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startAug 2010
- Primary completionApr 2015
- Study completion19 Jun 2015
Why it stopped: Medtronic terminated the study since Foretevo product was no longer marketed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Paul de Vries, MD, Principal investigator, St Antonius Hospital - Nieuwegein, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276249
- Sponsor's protocol ID
- CD03335-01
- Status last verified
- Oct 2021
- First submitted
- 11 Jan 2011
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Deaton DH. Future technologies to address the failed endoprosthesis. Semin Vasc Surg. 2009 Jun;22(2):111-8. doi: 10.1053/j.semvascsurg.2009.04.010.
PubMed 19573751Deaton DH, Mehta M, Kasirajan K, Chaikof E, Farber M, Glickman MH, Neville RF, Fairman RM. The phase I multicenter trial (STAPLE-1) of the Aptus endovascular repair system: results at 6 months and 1 year. J Vasc Surg. 2009 Apr;49(4):851-7; discussion 857-8. doi: 10.1016/j.jvs.2008.10.064.
PubMed 19341879
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STAPLE-International Post-Market Registry
- ClinicalTrials.gov ID
- NCT01276249
- Acronym / sponsor ID
- CD03335-01
- Conditions
- Aortic Aneurysm, Abdominal, Aorto Iliac Aneurysm
- Keywords
- Aptus Endosystem, EndoStaple, Endograft, Stent Graft, Abdominal Aortic Aneurysm, Heli-FX, EndoAnchor
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Medtronic terminated the study since Foretevo product was no longer marketed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- 19 Jun 2015 (actual)
- First posted
- 13 Jan 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.
The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.
Detailed description
The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.
All subjects diagnosed with a qualifying AAA suitable for elective endovascular repair, who meet the inclusion/exclusion criteria for the registry, are eligible for enrollment and should be offered informed consent to participate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fortevo Endograft | – | Device: Fortevo EndograftAll subjects diagnosed with a qualifying AAA suitable for elective endovascular repair, who meet the inclusion/exclusion criteria for the registry, are eligible for enrollment if treated with the Fortevo Endograft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair.
Key inclusion criteria (13 listed)
- Patient ≥ 18 years old
- Patient has given written informed consent
- Patient has a life expectancy > 1 year
- Patient is willing to comply with follow-up evaluations
- Patient's AAA meets at least one of the following criteria:
Key exclusion criteria (8 listed)
- Patient is participating in a concurrent clinical study which may confound STAPLE-International Registry results
- Patient has a symptomatic AAA
- Patient's AAA has a proximal aortic neck angle that is > 60 degrees between the infrarenal neck and the long axis of the aneurysm
- Patient has irregularly-shaped plaque that would inhibit sealing stent apposition
- Patient has aortic mural pathology that is ≥ 2mm in thickness over ≥ 50% of the circumference of the proximal fixation site
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 |
|---|---|---|
| Fortevo EndograftThe Fortevo Endograft, Main Body and Iliac Lumen Delivery System are indicated for the endovascular treatments of patients with infrarenal abdominal aortic aneurysms or aortic-iliac aneurysms having suitable morphology for endovascular repair. | Device | Fortevo Endograft |
Primary outcome
Technical Success
Time frame: Within 24 hours of the Index procedure
The first primary endpoint is primary technical success. It consists of the following items: * Successful arterial access * Successful deployment of the Fortevo Endograft with secure proximal and distal fixation * Absence of type I or III endoleaks * Patent Fortevo Endograft without significant twist, kinking, or obstruction
Major Adverse Events (MAE)
Time frame: Within 1-Month of Implantation
The second primary endpoint is associated with the safety profile of the device, and is defined as the percent of patients experiencing one or more of major adverse events (MAE) within one month of implantation. 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)
1 secondary outcome
Clinical Success and Safety of the Fortevo Endograft and Heli-FX EndoAnchor System components
Time frame: 1-Month, 6-Months and 12-Months
Results and safety
The study was stopped early (reason given: Medtronic terminated the study since Foretevo product was no longer marketed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Background: PubMed 19573751Deaton DH. Future technologies to address the failed endoprosthesis. Semin Vasc Surg. 2009 Jun;22(2):111-8. doi: 10.1053/j.semvascsurg.2009.04.010.
- Results publication: PubMed 19341879Deaton DH, Mehta M, Kasirajan K, Chaikof E, Farber M, Glickman MH, Neville RF, Fairman RM. The phase I multicenter trial (STAPLE-1) of the Aptus endovascular repair system: results at 6 months and 1 year. J Vasc Surg. 2009 Apr;49(4):851-7; discussion 857-8. doi: 10.1016/j.jvs.2008.10.064.
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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.
Jean-Paul de Vries, MD principal investigator
St Antonius Hospital - Nieuwegein, Netherlands
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm, Abdominal and Aorto Iliac Aneurysm, run by Medtronic Cardiovascular at 9 sites in 6 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 13 inclusion and 8 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: stopped early, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Spain, Canada, Greece, Italy and 1 more country. 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 was stopped early (reason given: Medtronic terminated the study since Foretevo product was no longer marketed). Results are not available in the source record.
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?
Technical Success (time frame: Within 24 hours of the Index procedure). 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 NCT01276249, which also lists 2 linked publications.
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 2 Nov 2021.