Abdominal Aortic AneurysmsPhase 1NCT01346943
The Altura Abdominal Aortic Aneurysm (AAA) Endograft Safety and Feasibility Study
A Phase 1 study testing Altura Medical Abdominal Aortic Aneurysm Stent-Graft in people with Abdominal Aortic Aneurysms, run by Altura Medical Inc. at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety of deploying and implanting the Altura Abdominal Aortic Aneurysm (AAA) Endograft in the treatment of abdominal aortic aneurysms in subjects who are candidates for open surgical aneurysm repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms
- What is being tested?
- Altura Medical Abdominal Aortic Aneurysm Stent-Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2011to May 2019
- Phase
- Phase 1
- 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
- 18 years or older.
- Subject or subject's legal representative understands and has signed an informed consent.
- Infrarenal aneurysmal neck diameter between 18 and 28mm, inclusive.
- Abdominal aneurysm neck angulation < 45 degrees.
- Infrarenal non-aneurysmal neck >/= 15mm in length.
- Abdominal aneurysm >4.5cm and growth >1.0 cm/yr.
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- Limited iliac artery tortuosity.
- Iliac artery fixation length of >/= 15mm.
- Iliac artery diameter between 8 and 19 mm, inclusive.
- Iliac artery diameter accessible by a 14 Fr introducer.
- Subject is a candidate for open surgical repair of abdominal aortic aneurysm.
- Patent iliac or femoral arteries access vessels, size and morphology to allow endovascular access of 14 Fr introducer sheaths and catheters.
- Subject has > one year life expectancy.
- Subject is not placed at additional risk while waiting for additional imaging necessary for vascular treatment.
- Subject is American Society of Anesthesiology (ASA) grade 1 through 3, inclusive.
- Subject is able and willing to comply with 30 day, six (6) month, one (1) year and 2 (two) year follow-up.
Who cannot join
- Subject has an acutely ruptured or leaking or emergent aneurysm.
- Subject has a dissecting aneurysm.
- Subject has a mycotic or infected aneurysm.
- Subject has current vascular injury due to trauma.
- Subject's aneurysm is thoracic or suprarenal.
- Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
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- Subject has thrombus, calcification and/or plaque that may compromise sealing
- Subject has had a myocardial infarction within six (6) months prior to enrollment.
- Subject has current angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia, or valvular disease.
- Subject has undergone other major surgery within the 30 days prior to enrollment.
- Subject is pregnant or nursing.
- Known allergy to nitinol or polyester or contrast material that cannot be pretreated.
- Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
- Subject has connective tissue disease (e.g., Marfan's syndrome).
- Subject has a bleeding disorder or anemia defined as hemoglobin < 9.0 mg/dL.
- Subject is hypercoagulable.
- Subject is on dialysis or has compromised renal function as reflected by a serum creatinine >2.2 mg/dL.
- Subject has compromised hepatic function as measured by SGPT (ALT) > three (3) times the upper limit of normal.
- Subject has active systemic infection.
- Subject is participating in another research study involving an investigational agent for the treatment of AAA.
- Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: The Altura AAA Endograft Safety and Feasibility Study For Exclusion of Abdominal Aortic Aneurysms
The purpose of this study is to evaluate the safety of deploying and implanting the Altura Abdominal Aortic Aneurysm (AAA) Endograft in the treatment of abdominal aortic aneurysms in subjects who are candidates for open surgical aneurysm repair.
- Conditions
- Abdominal Aortic Aneurysms
- Being tested
- Altura Medical Abdominal Aortic Aneurysm Stent-Graft
- Keywords
- Abdominal Aortic Aneurysms, 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.
Altura Medical Abdominal Aortic Aneurysm Stent-GraftDevice
Also called Altura Medical AAA Stent Graft System
Altura Medical AAA Stent Graft System
| Study group | Role | What they receive |
|---|---|---|
| AAA Stent Graft System | Experimental | Altura Medical AAA Stent Graft System Receives: Device: Altura Medical Abdominal Aortic Aneurysm Stent-Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of major adverse events.
Adverse events defined as the composite endpoint of death, significant blood loss requiring intervention, respiratory failure, myocardial infarction, renal failure, paralysis, stroke, bowel ischemia and/or device migration causing vascular compromise.
Measured: 30 days
Secondary outcomes (1)
Feasibility of device defined by clinical and technical success
Evaluate the feasibility of using Altura AAA Endograft. Feasibility is comprised of acute clinical and technical success measured at the time of procedure. Long-term safety will be evaluated at 6 months, 1 year and 2 years.
Measured: 6 months, 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Altura Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Albrecht Kramer, MD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346943
- Sponsor's protocol ID
- ALTURA-FIM-1
- Status last verified
- Jan 2015
- First submitted
- 2 May 2011
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Altura AAA Endograft Safety and Feasibility Study For Exclusion of Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT01346943
- Acronym / sponsor ID
- ALTURA-FIM-1
- Conditions
- Abdominal Aortic Aneurysms
- Keywords
- Abdominal Aortic Aneurysms, AAA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Altura Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 4 May 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 purpose of this study is to evaluate the safety of deploying and implanting the Altura Abdominal Aortic Aneurysm (AAA) Endograft in the treatment of abdominal aortic aneurysms in subjects who are candidates for open surgical aneurysm repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AAA Stent Graft System | Experimental | Device: Altura Medical Abdominal Aortic Aneurysm Stent-GraftAltura Medical AAA 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)
- 18 years or older.
- Subject or subject's legal representative understands and has signed an informed consent.
- Infrarenal aneurysmal neck diameter between 18 and 28mm, inclusive.
- Abdominal aneurysm neck angulation < 45 degrees.
- Infrarenal non-aneurysmal neck >/= 15mm in length.
Key exclusion criteria (21 listed)
- Subject has an acutely ruptured or leaking or emergent aneurysm.
- Subject has a dissecting aneurysm.
- Subject has a mycotic or infected aneurysm.
- Subject has current vascular injury due to trauma.
- Subject's aneurysm is thoracic or suprarenal.
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 |
|---|---|---|
| Altura Medical Abdominal Aortic Aneurysm Stent-GraftAlso: Altura Medical AAA Stent Graft SystemAltura Medical AAA Stent Graft System | Device | AAA Stent Graft System |
Primary outcome
The rate of major adverse events.
Time frame: 30 days
Adverse events defined as the composite endpoint of death, significant blood loss requiring intervention, respiratory failure, myocardial infarction, renal failure, paralysis, stroke, bowel ischemia and/or device migration causing vascular compromise.
1 secondary outcome
Feasibility of device defined by clinical and technical success
Time frame: 6 months, 1 year and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
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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.
Albrecht Kramer, MD principal investigator
Pontificia Universidad Catolica de Chile
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Altura Medical Abdominal Aortic Aneurysm Stent-Graft in people with Abdominal Aortic Aneurysms, run by Altura Medical Inc. at 2 sites in 2 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 16 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 15 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile, Latvia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
The rate of major adverse events. (time frame: 30 days). 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 15 Jan 2015.