Abdominal Aortic AneurysmPhase 1/2NCT00235118
Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)
A Phase 1/2 study testing Cordis AAA Bilateral Device in people with Abdominal Aortic Aneurysm, run by Cordis US Corp. at 1 site in United States.
Trial summary
The objective of this study is to assess the safety and effectiveness of the Cordis Bilateral AAA device and its Delivery System compared to open surgical repair for the treatment of Abdominal Aortic Aneurysm (AAA). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Cordis AAA Bilateral Device
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1999to Feb 2006
- Phase
- Phase 1/2
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anatomic (stent-graft)
- Aortic Aneurysm Diameter
- > 4.5 cm
- Those aortic aneurysms < 4.5 cm that are at least 1.5 times the diameter of the aorta with a size increase of 5 mm or greater over a six month period will also be included for possible treatment.
- Aorto-iliac aneurysms in which the aortic aneurysm is < 4.5 cm but the iliac artery aneurysms are > 3.0 cm in diameter or there is evidence of recent expansion (5 mm or greater over a six month period) in iliac aneurysms < 3.0 cm.
- Saccular aortic aneurysms > 3.0 cm.
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- Aortic Neck
- Diameter > 17 mm and < 28 mm (Phase I)
- Diameter > 14 mm and < 28 mm (Phase II)
- Angulation Neck Length < 45° > 15 mm <60° > 25 mm
- Iliac Arteries
- Diameter > 8 mm and < 18 mm (Phase I and Phase II)
- At least one common iliac artery with a cuff > 15 mm.
- Diameter Aortic Neck Common Iliac 26-28 mm 13-18 mm 23-25.9 mm 10-17 mm 20-22.9 mm 9-15 mm 17-19.9 mm 8-13 mm 14-16.9 mm 8-11mm
- NOTE: An aortic diameter cannot be treated if the iliac diameter is not in the same range (e.g. 26-28 mm aortic necks must be in conjunction with 13-18 mm common iliacs).
- Anatomic (surgical controls)
- Surgical controls will be required to meet only the aortic or aorto-iliac aneurysm size requirements for anatomic inclusion criteria.
- Aortic Aneurysm Diameter
- > 4.5 cm
- Those aortic aneurysms <4.5 cm that are at least 1.5 times the diameter of the aorta with a size increase of 5 mm or greater over a six month period will also be included for possible treatment.
- Aorto-iliac aneurysm in which the aortic aneurysm is <4.5 cm but the iliac artery aneurysm are >3.0 cm in diameter or there is evidence of recent expansion (5 mm or greater over a six month period) in iliac aneurysms <3.0 cm.
- Saccular aortic aneurysms > 3.0 cm.
- Clinical (stent-graft)
- Males and non-pregnant females > 40 years of age.
- Clinical (surgical controls)
- Surgical control patients will be required to meet all of the above-stated stent-graft clinical inclusion criteria.
Who cannot join
- Anatomic (stent-graft)
- Aortic Aneurysm Diameter
- < 4.5 cm that are not at least 1.5 times the diameter of the aorta with evidence of a size increase of 5 mm or greater within a six month period.
- Aorto-iliac Aneurysms
- < 3.0 cm in diameter unless evidence of recent expansion (5 mm or greater within a six month period).
- The iliac portion of the aneurysm extending to the bifurcation bilaterally which would necessitate covering both internal iliac arteries with the device.
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- Aortic Neck
- Diameter < 17 mm and > 28 mm (Phase I)
- Diameter < 14 and >28 (Phase II)
- Thrombus lined
- Highly calcified
- NOTE: See inclusion criteria for length below the renals and degree of angulation.
- Iliac Arteries
- < 8 mm and > 18 mm (native) (Phase I and Phase II)
- Highly calcified (common)
- Neither common iliac artery with a cuff > 15 mm.
- NOTE: See inclusion criteria for aortic neck and iliac artery diameters.
- Anatomic (surgical controls)
- Surgical controls will be excluded based only on the aortic or aorto-iliac aneurysm size requirements for anatomic exclusion criteria.
- Aortic Aneurysm Diameter
- < 4.5 cm that are not at least 1.5 times the diameter of the aorta with evidence of a size increase of 5 mm or greater within a six month period.
- Aorto-Iliac Aneurysms
- < 3.0 cm in diameter unless evidence of recent expansion (5 mm or greater within a six month period).
- The iliac portion of the aneurysm extending to the bifurcation bilaterally which would necessitate surgically covering both internal iliac arteries.
- Clinical (stent-graft)
- Ruptured abdominal aortic aneurysm.
- Renal insufficiency - creatinine level > 2.5 mg/dl.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Safety and Effectiveness of the Cordis Bilateral AAA Device Compared to Open Surgical Repair for the Treatment of Abdominal Aortic Aneurysm
The objective of this study is to assess the safety and effectiveness of the Cordis Bilateral AAA device and its Delivery System compared to open surgical repair for the treatment of Abdominal Aortic Aneurysm (AAA).
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Cordis AAA Bilateral Device
- 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.
Cordis AAA Bilateral DeviceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary success is defined as freedom from all of the following: rupture of aneurysm, enlargement of aneurysm > 0.5 cm on CT scan, with or without endoleak, as compared to any previous measurement, symptomatic aneurysm requiring treatment.
The absence of major complications at thirty days defined as arterial thrombosis, respiratory impairment, renal failure, myocardial infarction (M.I.) and stroke in combination with the absence of major complications at one year.
Secondary outcomes (1)
· Technical success defined as the successful access and deployment of the device at the appropriate anatomic location with aneurysmal exclusion determined by angiography at the time of deployment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startDec 1999
- Study completionFeb 2006
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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Marin, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235118
- Sponsor's protocol ID
- P98-4601
- Status last verified
- Oct 2005
- First submitted
- 6 Oct 2005
- Last updated
- 9 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Safety and Effectiveness of the Cordis Bilateral AAA Device Compared to Open Surgical Repair for the Treatment of Abdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT00235118
- Acronym / sponsor ID
- P98-4601
- Conditions
- Abdominal Aortic Aneurysm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Dec 1999
- Study completion
- Feb 2006
- First posted
- 10 Oct 2005 (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 objective of this study is to assess the safety and effectiveness of the Cordis Bilateral AAA device and its Delivery System compared to open surgical repair for the treatment of Abdominal Aortic Aneurysm (AAA).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Anatomic (stent-graft)
- Aortic Aneurysm Diameter
- > 4.5 cm
- Those aortic aneurysms < 4.5 cm that are at least 1.5 times the diameter of the aorta with a size increase of 5 mm or greater over a six month period will also be included for possible treatment.
- Aorto-iliac aneurysms in which the aortic aneurysm is < 4.5 cm but the iliac artery aneurysms are > 3.0 cm in diameter or there is evidence of recent expansion (5 mm or greater over a six month period) in iliac aneurysms < 3.0 cm.
Key exclusion criteria (27 listed)
- Anatomic (stent-graft)
- Aortic Aneurysm Diameter
- < 4.5 cm that are not at least 1.5 times the diameter of the aorta with evidence of a size increase of 5 mm or greater within a six month period.
- Aorto-iliac Aneurysms
- < 3.0 cm in diameter unless evidence of recent expansion (5 mm or greater within a six month period).
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 |
|---|---|---|
| Cordis AAA Bilateral Device | Device | – |
Primary outcome
Primary success is defined as freedom from all of the following: rupture of aneurysm, enlargement of aneurysm > 0.5 cm on CT scan, with or without endoleak, as compared to any previous measurement, symptomatic aneurysm requiring treatment.
The absence of major complications at thirty days defined as arterial thrombosis, respiratory impairment, renal failure, myocardial infarction (M.I.) and stroke in combination with the absence of major complications at one year.
1 secondary outcome
· Technical success defined as the successful access and deployment of the device at the appropriate anatomic location with aneurysmal exclusion determined by angiography at the time of deployment.
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 9 Dec 2005.
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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.
Michael Marin, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cordis AAA Bilateral Device in people with Abdominal Aortic Aneurysm, run by Cordis US Corp. 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 26 inclusion and 27 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 9 Dec 2005. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary success is defined as freedom from all of the following: rupture of aneurysm, enlargement of aneurysm > 0.5 cm on CT scan, with or without endoleak, as compared to any previous measurement, symptomatic aneurysm requiring treatment.. 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?
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 9 Dec 2005.