Abdominal Aortic AneurysmNCT01348828
Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System
A study testing Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System) in people with Abdominal Aortic Aneurysm, run by Endologix at 8 sites in 6 countries.
Trial summary
The aim of this study is to evaluate the safety and feasibility of the Endologix Fenestrated Stent Graft System for the endovascular repair of juxtarenal or pararenal aortic aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 19 Oct 2011to 20 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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 >= 70
- SMA to aortoiliac bifurcation length >=90mm
- Proximal non-aneurysmal aortic neck below the SMA with diameter 18 to 34 mm, length >=15mm and angle <=60° to the aneurysm sac
- Angle <=60° (clock face) between the SMA and CA
Show all 9Show fewer
- Renal arteries both at or below the SMA by <=35mm and within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other
- Common iliac artery distal fixation site with: distal fixation length >=15mm, with diameter >=10 mm and <=23 mm and angle <=90° to the aortic bifurcation
- Ability to preserve at least one hypogastric artery
Who cannot join
- Life expectancy <2 years 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
Show all 23Show fewer
- Ruptured, leaking, or mycotic aneurysm
- Aortic dissection 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
- Recent(within prior three months)myocardial infarction
- Prior renal transplant
- Length of either renal artery to be stented <12mm
- Significant occlusive disease or calcification of either renal artery (>70%)
- 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
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
United States3 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Indiana
Indianapolis, Indiana, 46202
UCLA
Los Angeles, California, 90024
About this study
Official title: Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms
The aim of this study is to evaluate the safety and feasibility of the Endologix Fenestrated Stent Graft System for the endovascular repair of juxtarenal or pararenal aortic aneurysms.
Read the detailed description
The Endologix Fenestrated Stent Graft System that will be used in this study has three components, listed below:
- Endologix unibody bifurcated stent graft
- Endologix fenestrated proximal extension stent graft
- Endologix renal stent graft
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)
- Keywords
- Abdominal Aortic Aneurysm, Fenestrated, Renal Stent, Juxtarenal, Pararenal, Endologix, Renal
- 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.
Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)Device
Also called Ventana, Xpand
Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed. Receives: Device: Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Major adverse events defined as:
- All-cause death
- Bowel ischemia
- Myocardial infarction
- Paraplegia
- Renal failure
- Respiratory failure
- Stroke
- Blood loss >=1,000cc
Measured: 30 days
Secondary outcomes (13)
Feasibility/Effectiveness
Successful device delivery and deployment with patency of the renal and aortic endografts without Type I/III endoleak.
- Treatment Success is defined as procedural technical success with device patency and the absence of type I/III endoleak
- Procedural Technical Success is defined as a subject with successful implant.
- Aneurysm Rupture: An aneurysm is a balloon-like bulge of an artery wall. As an aneurysm grows it puts pressure on nearby structures and may eventually rupture.
- Clinically Significant Device Migration: Core Lab reported aortic stent graft movement >10mm
- Type I/III/IV Endoleak: Core Lab reported endoleak: between the endograft and the vessel either at the proximal attachment point (Type IA), or at the distal attachment point (Type IB), or between endograft components (Type III) or transgraft (Type IV).
- Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery).
Measured: 1 Year
Procedural/In-hospital Evaluations
Fluoroscopy time, Renal Artery Cannulation time and procedure time
Measured: Procedurally and to hospital discharge
Mortality
All-cause and aneurysm-related
Measured: Procedurally and to 5 Years
Major Adverse Events
All-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, blood loss >1,000cc
Measured: >30 Days to 5 Years
Number of Participants With Renal Dysfunction
Renal Dysfunction, Renal Dysfunction In subjects with baseline eGFR>=60 and Renal Dysfunction In subjects with baseline eGFR <60
Measured: 30 Days, 6 Months and Years 1 to 5
Aneurysm Rupture
Internal bleeding or leaking of blood from the aneurysm subsequent to the index procedure
Measured: Procedurally and to 5 Years
Conversion to Open Repair
Open surgical repair of the aortic aneurysm due to unsuccessful delivery or deployment of the stent graft, due to complications or other clinical situations that precluded successful endovascular treatment, or at any time following initial successful endovascular treatment for any reason
Measured: Procedurally and to 5 Years
Device Integrity
Device Migration, Ventana Stent Fracture, Left renal stent fracture, right renal stent fracture, stent Kinking/Compression
Measured: 30 Days, 6 Months, and Years 1 to 5
Stent Graft Patency
Ventana and Bifurcated occlusion, LRA (Left renal artery) occlusion and RRA (right renal artery) occlusion
Measured: 30 Days, 6 Months, and Years 1 to 5
Aneurysm Diameter Change
Change in aneurysm sac diameter - decrease > 5mm, Increase > 5mm, Stable (+/- 5mm) and No growth.
Measured: 6 Months, and Years 1 to 5
Secondary Procedures
Non-diagnostic intervention after the index procedure intended to correct or repair an endoleak (device-related: Type I (proximal or distal), Type III, Type IV; non-device related: Type II), device migration, or other device defect.
Measured: 30 Days, 6 Month and Years 1 to 5
Procedural/In-hospital Evaluations
Contrast volume and estimated blood loss
Measured: Procedurally and to hospital discharge
Procedural/In-hospital Evaluations
Time to hospital discharge
Measured: Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study start19 Oct 2011
- Primary completionMay 2013
- Study completion20 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Clair, MD, Principal investigator, The Cleveland ClinicAndrew Holden, MD, Principal investigator, Auckland City HospitalRenato Mertens, MD, Principal investigator, Hospital Universidad Catolica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348828
- Sponsor's protocol ID
- CP-0003
- Status last verified
- Sep 2021
- First submitted
- 3 May 2011
- Last updated
- 15 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Mertens R, Bergoeing M, Marine L, Valdes F, Kramer A, Vergara J. Ventana fenestrated stent-graft system for endovascular repair of juxtarenal aortic aneurysms. J Endovasc Ther. 2012 Apr;19(2):173-8. doi: 10.1583/11-3706.1.
PubMed 22545881
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms
- ClinicalTrials.gov ID
- NCT01348828
- Acronym / sponsor ID
- CP-0003
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal Aortic Aneurysm, Fenestrated, Renal Stent, Juxtarenal, Pararenal, Endologix, Renal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- EndologixIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2011 (actual)
- Primary completion
- May 2013 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Posted 15 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the safety and feasibility of the Endologix Fenestrated Stent Graft System for the endovascular repair of juxtarenal or pararenal aortic aneurysms.
Detailed description
The Endologix Fenestrated Stent Graft System that will be used in this study has three components, listed below:
- Endologix unibody bifurcated stent graft
- Endologix fenestrated proximal extension stent graft
- Endologix renal stent graft
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 >= 70
- SMA to aortoiliac bifurcation length >=90mm
- Proximal non-aneurysmal aortic neck below the SMA with diameter 18 to 34 mm, length >=15mm and angle <=60° to the aneurysm sac
Key exclusion criteria (23 listed)
- Life expectancy <2 years 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 |
|---|---|---|
| Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)Also: Ventana, XpandEndovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System | Device | Single Arm |
Primary outcome
Primary Safety Endpoint
Time frame: 30 days
Major adverse events defined as: * All-cause death * Bowel ischemia * Myocardial infarction * Paraplegia * Renal failure * Respiratory failure * Stroke * Blood loss >=1,000cc
13 secondary outcomes
Feasibility/Effectiveness
Time frame: 1 Year
Procedural/In-hospital Evaluations
Time frame: Procedurally and to hospital discharge
Mortality
Time frame: Procedurally and to 5 Years
Major Adverse Events
Time frame: >30 Days to 5 Years
Number of Participants With Renal Dysfunction
Time frame: 30 Days, 6 Months and Years 1 to 5
Aneurysm Rupture
Time frame: Procedurally and to 5 Years
Conversion to Open Repair
Time frame: Procedurally and to 5 Years
Device Integrity
Time frame: 30 Days, 6 Months, and Years 1 to 5
Stent Graft Patency
Time frame: 30 Days, 6 Months, and Years 1 to 5
Aneurysm Diameter Change
Time frame: 6 Months, and Years 1 to 5
Secondary Procedures
Time frame: 30 Days, 6 Month and Years 1 to 5
Procedural/In-hospital Evaluations
Time frame: Procedurally and to hospital discharge
Procedural/In-hospital Evaluations
Time frame: Discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22545881Mertens R, Bergoeing M, Marine L, Valdes F, Kramer A, Vergara J. Ventana fenestrated stent-graft system for endovascular repair of juxtarenal aortic aneurysms. J Endovasc Ther. 2012 Apr;19(2):173-8. doi: 10.1583/11-3706.1.
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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.
Daniel Clair, MD principal investigator
The Cleveland Clinic
Andrew Holden, MD principal investigator
Auckland City Hospital
Renato Mertens, MD principal investigator
Hospital Universidad Catolica
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System) in people with Abdominal Aortic Aneurysm, run by Endologix at 8 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 9 inclusion and 23 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 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Chile, France, Netherlands, New Zealand 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?
Yes. Results are posted in the registry (first posted 15 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
On the ClinicalTrials.gov record for NCT01348828, 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 15 Oct 2021.