Abdominal Aortic AneurysmsELEVATENCT01991756
Safety and Performance of Altura Endograft in Abdominal Aortic Aneurysm (AAA) Endovascular Repair
An observational study of Abdominal Aortic Aneurysms, run by Altura Medical Inc. at 4 sites in Germany.
Trial summary
The primary objective of the study is to evaluate the acute safety of deploying and implanting the Altura Endograft in the treatment of AAA in subjects who are candidates for endovascular 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 Endograft System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 4 sitesGermany
- Study dates
- Apr 2014to Mar 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: Subjects diagnosed with infrarenal abdominal aortic aneurysm (AAA) disease with suitable aneurysm morphology for endovascular repair.
Who may be able to join
- 18 years or older
- Understands and has signed an Informed Consent
- Candidate for endovascular or open surgical repair of an infrarenal aortic or aorto-iliac aneurysm
- Abdominal aneurysm > 45 mm or aneurysm growth of > 10 mm/year
- Abdominal aneurysm neck angulation ≤ 60 degrees
- Infrarenal non-aneurysmal neck 15 mm
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- Infrarenal non-aneurysmal neck diameter between 18 and 28 mm, inclusive
- Iliac artery landing zone 15 mm in length
- Iliac artery landing zone diameter between 8 and 18 mm, inclusive
- Patent iliac and femoral arteries, access vessels, size and morphology, to allow endovascular access of a minimum 14 Fr introducer sheath and catheter
- Ability to preserve at least one hypogastric artery
- Life expectancy > one year
- American Society of Anesthesiology (ASA) grade 1 through 3, inclusive
- Able and willing to comply with follow-up visits at 30 days, 6 and 12 months and annually through 5 years
Who cannot join
- Pregnant or nursing
- An acutely ruptured, leaking or emergent aneurysm
- An aortic dissection (Type A or B)
- A mycotic, infected or inflammatory aneurysm
- A thoracic, suprarenal or juxtarenal aneurysm
- Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm or an aorto-iliac aneurysm
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- Severe iliac artery tortuosity
- Thrombus, calcification and/or plaque that may complicate sealing
- Evidence or history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the past 3 months
- Current angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia or valvular disease
- Had or plans to have an unrelated major surgical or interventional procedure within 1 month before or after implantation of the study device
- Significant (>80%) diameter renal artery stenosis which could not be readily treated
- Known sensitivity or allergy to nitinol or polyester
- Known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment
- Contraindication to antiplatelet, anticoagulant or thrombolytic therapy;
- Coagulopathy or uncontrolled bleeding disorder
- History of heparin-induced thrombocytopenia (HIT)
- Clinically and morbidly obese such that the required imaging would be prevented
- Connective tissue disease (e.g., Marfan's or Ehlers-Danlos syndromes)
- Currently on dialysis or has compromised renal function as reflected by a serum creatinine >2.0 mg/dL
- Compromised hepatic function
- Active infection at the time of the index procedure
- End-stage chronic obstructive pulmonary disorder (COPD)
- Religious, cultural or other objections to the receipt of blood or blood products
- Participating in another research study involving an investigational device or drug which may potentially affect study results
- 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
4 sites in 1 country.
Germany4 sites
Uniklink
Freiburg im Breisgau
University Heart Center
Hamburg-Eppendorf
Park-Krankenhaus Leipzig
Leipzig
Sankt Bonifatius Hospital
Lingen
About this study
Official title: ELEVATE International: Kissing Endografts for Peripheral AAA Exclusion
The primary objective of the study is to evaluate the acute safety of deploying and implanting the Altura Endograft in the treatment of AAA in subjects who are candidates for endovascular repair.
Secondary objectives are to evaluate the acute and longer-term safety and performance of the Altura Endograft through 5 years.
Read the detailed description
The primary safety endpoint of the study is freedom from Major Adverse Events (MAE), a composite endpoint consisting of death, stroke, paraplegia, myocardial infarction, respiratory failure, renal failure, bowel ischemia and blood loss ≥ 1000 mL.
- Conditions
- Abdominal Aortic Aneurysms
- Being tested
- Altura Endograft System
- 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 Endograft SystemDevice
Subjects with a documented untreated, unruptured, infrarenal abdominal aorto-iliac aneurysm.
| Study group | Role | What they receive |
|---|---|---|
| AAA | Subjects with a documented untreated, unruptured, infrarenal abdominal aorto-iliac aneurysm will be treated with the Altura Endograft System. Receives: Device: Altura Endograft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Freedom from Major Adverse Events (MAE), a composite endpoint consisting of:
- Death
- Stroke
- Paraplegia
- Myocardial infarction
- Respiratory failure
- Renal failure
- Bowel ischemia
- Blood loss ≥ 1000 mL
Measured: 30 days
Secondary outcomes (1)
Secondary Safety Endpoint
- Major Adverse Events (MAE)
- Aneurysm-related death
- Type I and III endoleaks
- AAA rupture
- Re-intervention to correct Type I or Type III endoleaks, migration, occlusion, narrowing, stenosis, kinking or fracture
Measured: 30 days, 6 and 12 months and annually through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startApr 2014
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Altura Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dierk Scheinert, MD, PhD, Principal investigator, Park-Krenkenhaus Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991756
- Sponsor's protocol ID
- ALTURA-ELE-1
- Acronym
- ELEVATE
- Status last verified
- Jan 2015
- First submitted
- 18 Nov 2013
- 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
- ELEVATE International: Kissing Endografts for Peripheral AAA Exclusion
- ClinicalTrials.gov ID
- NCT01991756
- Acronym / sponsor ID
- ELEVATE / ALTURA-ELE-1
- Conditions
- Abdominal Aortic Aneurysms
- Keywords
- Abdominal Aortic Aneurysms, AAA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Altura Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 25 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 primary objective of the study is to evaluate the acute safety of deploying and implanting the Altura Endograft in the treatment of AAA in subjects who are candidates for endovascular repair.
Secondary objectives are to evaluate the acute and longer-term safety and performance of the Altura Endograft through 5 years.
Detailed description
The primary safety endpoint of the study is freedom from Major Adverse Events (MAE), a composite endpoint consisting of death, stroke, paraplegia, myocardial infarction, respiratory failure, renal failure, bowel ischemia and blood loss ≥ 1000 mL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AAA | – | Device: Altura Endograft SystemSubjects with a documented untreated, unruptured, infrarenal abdominal aorto-iliac aneurysm will be treated with the Altura Endograft System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with infrarenal abdominal aortic aneurysm (AAA) disease with suitable aneurysm morphology for endovascular repair.
Key inclusion criteria (14 listed)
- 18 years or older
- Understands and has signed an Informed Consent
- Candidate for endovascular or open surgical repair of an infrarenal aortic or aorto-iliac aneurysm
- Abdominal aneurysm > 45 mm or aneurysm growth of > 10 mm/year
- Abdominal aneurysm neck angulation ≤ 60 degrees
Key exclusion criteria (26 listed)
- Pregnant or nursing
- An acutely ruptured, leaking or emergent aneurysm
- An aortic dissection (Type A or B)
- A mycotic, infected or inflammatory aneurysm
- A thoracic, suprarenal or juxtarenal aneurysm
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 Endograft SystemSubjects with a documented untreated, unruptured, infrarenal abdominal aorto-iliac aneurysm. | Device | AAA |
Primary outcome
Primary Safety Endpoint
Time frame: 30 days
Freedom from Major Adverse Events (MAE), a composite endpoint consisting of: * Death * Stroke * Paraplegia * Myocardial infarction * Respiratory failure * Renal failure * Bowel ischemia * Blood loss ≥ 1000 mL
1 secondary outcome
Secondary Safety Endpoint
Time frame: 30 days, 6 and 12 months and annually through 5 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.
Dierk Scheinert, MD, PhD principal investigator
Park-Krenkenhaus Leipzig
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysms, run by Altura Medical Inc. at 4 sites in Germany.
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 14 inclusion and 26 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 4 sites in Germany. 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?
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?
Primary Safety Endpoint (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.