Juxtarenal Aortic AneurysmNCT01437215
Pilot Study of the Endologix Fenestrated Stent Graft System
A study testing Ventana Fenestrated Stent Graft System in people with Juxtarenal Aortic Aneurysm and Pararenal Aortic Aneurysm, run by Endologix at 2 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether the Endologix fenestrated stent graft system is safe and feasible in the endovascular repair of juxtarenal or pararenal aortic aneurysm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Juxtarenal Aortic Aneurysm, Pararenal Aortic Aneurysm
- What is being tested?
- Ventana Fenestrated Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 Nov 2010to 28 Jul 2016
- Phase
- Interventional
- 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
- Informed consent understood and signed and pt agrees to all follow-up visits;
- Abdominal aortic aneurysm with diameter ≥5cm or ≥4cm which has increased by 0.5cm or more in the past six months
- Adequate iliac/femoral access compatible with the required delivery systems
- Non-aneurysmal infrarenal aortic neck <15mm in length
- Most caudal renal artery to aortoiliac bifurcation length at least 70mm
- Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length at least 15 mm; angle (clock face) <60° to the aneurysm sac;
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- Angle <60° (clock face) between the SMA and celiac artery
- Renal arteries both distal to the SMA by 0-35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other
- Iliac anatomy suitable for commercial bifurcated stent graft;
- Minimum 3cm overlap achievable between fenestrated and bifurcated stent grafts
Who cannot join
- Life expectancy <1 year as judged by the investigator;
- Psychiatric or other condition that may interfere with the study;
- Participating in the enrollment or 30-day follow-up phase of another clinical study;
- Known allergy to any device component;
- Coagulopathy or uncontrolled bleeding disorder;
- Contraindication to contrast media or anticoagulants;
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- Ruptured, leaking, dissecting, or mycotic aneurysm;
- Serum creatinine (S-Cr) level >2.0 mg/dL;
- Traumatic vascular injury;
- Active systemic or localized groin infection;
- Connective tissue disease (e.g., Marfan's Syndrome);
- Recent (within prior three months) cerebrovascular accident or myocardial infarction;
- Prior renal transplant;
- Length of either renal artery to be stented <13mm;
- Significant occlusive disease or calcification of either renal artery;
- An essential accessory renal artery;
- Indispensable inferior mesenteric artery;
- Untreated aneurysmal disease of the descending thoracic aorta;
- Clinically significant mural thrombus circumferentially in the suprarenal segment;
- Prior iliac artery stent implanted that may interfere with delivery system introduction;
- Unsuitable vascular anatomy
- Pregnancy (female patient of childbearing potential only)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Prospective, Multicenter, Single Arm Feasibility and Initial Safety Study of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms
The purpose of this study is to determine whether the Endologix fenestrated stent graft system is safe and feasible in the endovascular repair of juxtarenal or pararenal aortic aneurysm.
- Being tested
- Ventana Fenestrated Stent Graft System
- Keywords
- aneurysm, renal stent, juxtarenal, pararenal
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventana Fenestrated Stent Graft SystemDevice
Endovascular repair of juxtarenal or pararenal aortic aneurysm
| Study group | Role | What they receive |
|---|---|---|
| Fenestrated Endografting | Experimental | Not described Receives: Device: Ventana Fenestrated Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Number of Major Adverse Events (MAEs)
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc
Measured: 30 Days
Feasibility- Number of subjects with procedural success (stent graft patency) and absence of type I/III endoleaks or migration
Procedural Success with aortic/fenestrated and renal stent graft patency and absence of Type I/III endoleak or migration
Measured: 30 Days
Secondary outcomes (5)
Safety - Number of Major Adverse Events (MAEs)
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc
Measured: >30 Days to 5 Years
Adverse Events
All adverse events, whether serious or non-serious
Measured: Procedurally to 5 Years
Distal Blood Flow
Ankle-brachial index measurements
Measured: Discharge to 5 Years
Renal Dysfunction
eGFR reduction >30% from baseline
Measured: Discharge to 5 Years
Device Performance
Aortic, fenestrated, and renal stent graft integrity and patency; migration; endoleak; and aneurysm sac morphology
Measured: 30 Days to 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study start2 Nov 2010
- Primary completionSep 2011
- Study completion28 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juxtarenal 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437215
- Sponsor's protocol ID
- CP-0002
- Status last verified
- Feb 2024
- First submitted
- 17 Sep 2011
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Holden A, Mertens R, Hill A, Marine L, Clair DG. Initial experience with the Ventana fenestrated system for endovascular repair of juxtarenal and pararenal aortic aneurysms. J Vasc Surg. 2013 May;57(5):1235-45. doi: 10.1016/j.jvs.2012.10.125. Epub 2013 Mar 5.
PubMed 23466185
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single Arm Feasibility and Initial Safety Study of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms
- ClinicalTrials.gov ID
- NCT01437215
- Acronym / sponsor ID
- CP-0002
- Keywords
- aneurysm, renal stent, juxtarenal, pararenal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- EndologixIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2010 (actual)
- Primary completion
- Sep 2011 (actual)
- Study completion
- 28 Jul 2016 (actual)
- First posted
- 20 Sep 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 determine whether the Endologix fenestrated stent graft system is safe and feasible in the endovascular repair of juxtarenal or pararenal aortic aneurysm.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fenestrated Endografting | Experimental | Device: Ventana Fenestrated 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 (10 listed)
- Informed consent understood and signed and pt agrees to all follow-up visits;
- Abdominal aortic aneurysm with diameter ≥5cm or ≥4cm which has increased by 0.5cm or more in the past six months
- Adequate iliac/femoral access compatible with the required delivery systems
- Non-aneurysmal infrarenal aortic neck <15mm in length
- Most caudal renal artery to aortoiliac bifurcation length at least 70mm
Key exclusion criteria (22 listed)
- Life expectancy <1 year as judged by the investigator;
- Psychiatric or other condition that may interfere with the study;
- Participating in the enrollment or 30-day follow-up phase of another clinical study;
- Known allergy to any device component;
- Coagulopathy or uncontrolled bleeding disorder;
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 |
|---|---|---|
| Ventana Fenestrated Stent Graft SystemEndovascular repair of juxtarenal or pararenal aortic aneurysm | Device | Fenestrated Endografting |
Primary outcome
Safety - Number of Major Adverse Events (MAEs)
Time frame: 30 Days
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc
Feasibility- Number of subjects with procedural success (stent graft patency) and absence of type I/III endoleaks or migration
Time frame: 30 Days
Procedural Success with aortic/fenestrated and renal stent graft patency and absence of Type I/III endoleak or migration
5 secondary outcomes
Safety - Number of Major Adverse Events (MAEs)
Time frame: >30 Days to 5 Years
Adverse Events
Time frame: Procedurally to 5 Years
Distal Blood Flow
Time frame: Discharge to 5 Years
Renal Dysfunction
Time frame: Discharge to 5 Years
Device Performance
Time frame: 30 Days to 5 Years
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 16 Feb 2024.
- Derived from this study: PubMed 23466185Holden A, Mertens R, Hill A, Marine L, Clair DG. Initial experience with the Ventana fenestrated system for endovascular repair of juxtarenal and pararenal aortic aneurysms. J Vasc Surg. 2013 May;57(5):1235-45. doi: 10.1016/j.jvs.2012.10.125. Epub 2013 Mar 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventana Fenestrated Stent Graft System in people with Juxtarenal Aortic Aneurysm and Pararenal Aortic Aneurysm, run by Endologix 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 10 inclusion and 22 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 16 Feb 2024. 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, New Zealand. 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?
Safety - Number of Major Adverse Events (MAEs) (time frame: 30 Days). 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 NCT01437215, which also lists 1 linked publication.
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 16 Feb 2024.