Abdominal Aortic AneurysmNCT01491945
Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System
A study testing Ventana Fenestrated Stent Graft System in people with Abdominal Aortic Aneurysm, run by Endologix at 22 sites in United States.
Trial summary
The purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is safe and effective 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?
- Ventana Fenestrated Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 22 sitesUnited States
- Study dates
- 3 Mar 2013to 1 Aug 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
- Male or female at least 18 years old;
- Informed consent understood and signed and patient agrees to all follow-up visits;
- Have aortic aneurysm with maximum diameter ≥5.5cm, or between 4.5 and 5.5cm and rapidly expanding (>0.5cm in six months), or >50% larger than the normal aortic diameter
- Anatomically eligible for the Bifurcated System per the FDA-approved indications for use (IFU) and for the Fenestrated Stent Graft System:
- Adequate iliac/femoral access compatible with the required delivery systems
- Non-aneurysmal infrarenal aortic neck <15mm in length;
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- Most caudal renal artery to aortoiliac bifurcation length ≥70mm
- SMA to aortoiliac bifurcation length ≥90mm;
- Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length ≥15 mm; angle ≤60° to the aneurysm sac;
- Angle ≤60° (clock face) between the SMA and CA
- Renal arteries both distal to the SMA by ≤35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clock face angle of 90° to 210° to each other .Common iliac artery distal fixation site with: distal fixation length ≥15 mm; ability to preserve at least one hypogastric artery; diameter ≥10 mm and ≤23 mm; angle ≤90° to the aortic bifurcation.
- The Endologix Fenestrated Proximal Extension Stent must have the ability to overlap the bifurcated stent graft by at least 3cm.
- Aortic diameter at the most caudal renal artery of 18 to 36mm
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;
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- 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 or myocardial infarction;
- Prior renal transplant;
- Length of either renal artery to be stented <13mm;
- Significant occlusive disease of either renal artery (>70% stenosis);
- An essential accessory renal artery;
- Indispensable inferior mesenteric artery;
- 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)
- Existing renal stent;
- Pre-planned need for concomitant procedure (e.g. surgical conduit for vascular access, hypogastric artery embolization/coil, renal artery angioplasty)
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Emory University
Atlanta, Georgia, 30322
University of Alabama at Birmingham
Birmingham, Alabama, 35429
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of North Carolina
Chapel Hill, North Carolina, 27599
Charleston Area Medical Center
Charleston, West Virginia, 25304
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
John Muir Medical Center Concord, CA
Concord, California, 94520
VA Gainesville
Gainesville, Florida, 32608
Methodist Hospital
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
UCLA Medical Center
Los Angeles, California, 90095
Baptist East Hospital
Louisville, Kentucky, 40207
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Arizona Heart Institute
Phoenix, Arizona, 85016
UPMC
Pittsburgh, Pennsylvania, 15232
Mayo Clinic
Rochester, Minnesota, 55905
William Beaumont Hospital
Royal Oak, Michigan, 48073
Harborview Medical Center
Seattle, Washington, 98104
Barnes-Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: Prospective, Multicenter, Single Arm Safety and Effectiveness Trial of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms
The purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is safe and effective for the endovascular repair of juxtarenal or pararenal aortic aneurysms.
Read the detailed description
Study Objectives The objective of protocol CP-0004 is to study the safety and effectiveness of the Endologix Fenestrated System in the endovascular treatment of patients with juxtarenal and/or pararenal aortic aneurysms.
Study Design This clinical study is a prospective, non-randomized, multicenter study. The first patient enrolled at each site is designated as a 'Roll-In' group patient. Subsequently, enrolled patients are designated as 'Trial' group patients for primary endpoint analysis.
Primary Endpoint The primary safety endpoint is defined as the incidence of Major Adverse Events‡ (MAEs) within 30 days. The primary study effectiveness endpoint is Treatment Success at 1-year. This is defined as procedural technical success and the absence of aneurysm rupture; conversion to open surgical repair; Type I endoleak after 30 days; Type III endoleak; clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Ventana Fenestrated Stent Graft System
- Keywords
- Abdominal aortic aneurysm, Renal stent, Juxtarenal, Pararenal, Endovascular
- 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.
Ventana Fenestrated Stent Graft SystemDevice
The Ventana Fenestrated Stent Graft System consists of the following:
bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts
| Study group | Role | What they receive |
|---|---|---|
| Ventana Fenestrated Stent Graft System | Experimental | Ventana Fenestrated Stent Graft System 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 at 30 Days
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc
Measured: 30 Days
Effectiveness
- Treatment Success is defined as Procedural technical success and absence of aneurysm rupture, conversion to open repair, Type I endoleak after 30 days, Type III endoleak, clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect.
- Procedural Technical Success is defined as a subject with successful implant.
- 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
Secondary outcomes (11)
Safety- Number of Major Adverse Events > 30 Days to 5 Years
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
Renal Dysfunction
Renal Dysfunction is calculated at greater than 30% reduction starting at baseline
Measured: Discharge to 5 Years
Endoleaks
Endoleaks- Type IA, Type IB, Type II, Type IIIA, Type IIIB, Type IV, and Unknown Type
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: 30 Days to 5 Years
Clinical Utility Outcomes
Clinical Utility Outcomes consist of: fluoroscopy time, Bifurcated device placement time, Renal Artery Cannulation time, F-EVAR time and total procedure time.
Measured: At the time of the procedure
Time in ICU
Number of days spent in the intensive care unit (ICU)
Measured: In-Hospital
Time to Hospital Discharge
Number of days from the index procedure to discharge from the hospital.
Measured: Hospital Discharge (Post-Procedure)
Device Patency
Device patency- Ventana \& Bifurcated Occlusion, Left Renal Artery Occlusion, and Right Renal Artery Occlusion
Measured: 30 Days to 5 Years
Device Integrity
Device Integrity- Device Migration, Ventana Stent Fracture, Left Renal Stent Fracture, Right Renal Stent Fracture, and Stent Kinking/ Compression
Measured: 30 Days to 5 Years
Aneurysm Sac Morphology
Aneurysm Sac Morphology- Aneurysm Shape, Aneurysm Enlargement
Measured: 30 Days to 5 Years
Aneurysm Sac Diameter
Aneurysm Sac diameter changes
Measured: 30 Days to 5 Years
Clinical Utility Outcomes
Clinical Utility Outcomes consists of: contrast volume and estimated blood loss.
Measured: At the time of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study start3 Mar 2013
- Primary completionApr 2017
- Study completion1 Aug 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.
- 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel G Clair, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491945
- Sponsor's protocol ID
- CP-0004
- Status last verified
- Sep 2021
- First submitted
- 20 Oct 2011
- Last updated
- 15 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 Safety and Effectiveness Trial of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms
- ClinicalTrials.gov ID
- NCT01491945
- Acronym / sponsor ID
- CP-0004
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal aortic aneurysm, Renal stent, Juxtarenal, Pararenal, Endovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- EndologixIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2013 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 14 Dec 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 purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is safe and effective for the endovascular repair of juxtarenal or pararenal aortic aneurysms.
Detailed description
Study Objectives The objective of protocol CP-0004 is to study the safety and effectiveness of the Endologix Fenestrated System in the endovascular treatment of patients with juxtarenal and/or pararenal aortic aneurysms.
Study Design This clinical study is a prospective, non-randomized, multicenter study. The first patient enrolled at each site is designated as a 'Roll-In' group patient. Subsequently, enrolled patients are designated as 'Trial' group patients for primary endpoint analysis.
Primary Endpoint The primary safety endpoint is defined as the incidence of Major Adverse Events‡ (MAEs) within 30 days. The primary study effectiveness endpoint is Treatment Success at 1-year. This is defined as procedural technical success and the absence of aneurysm rupture; conversion to open surgical repair; Type I endoleak after 30 days; Type III endoleak; clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventana Fenestrated Stent Graft System | Experimental | Device: Ventana Fenestrated Stent Graft SystemVentana 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 (13 listed)
- Male or female at least 18 years old;
- Informed consent understood and signed and patient agrees to all follow-up visits;
- Have aortic aneurysm with maximum diameter ≥5.5cm, or between 4.5 and 5.5cm and rapidly expanding (>0.5cm in six months), or >50% larger than the normal aortic diameter
- Anatomically eligible for the Bifurcated System per the FDA-approved indications for use (IFU) and for the Fenestrated Stent Graft System:
- The Endologix Fenestrated Proximal Extension Stent must have the ability to overlap the bifurcated stent graft by at least 3cm.
Key exclusion criteria (25 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 |
|---|---|---|
| Ventana Fenestrated Stent Graft SystemThe Ventana Fenestrated Stent Graft System consists of the following: bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts | Device | Ventana Fenestrated Stent Graft System |
Primary outcome
Safety- Number of Major Adverse Events at 30 Days
Time frame: 30 Days
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc
Effectiveness
Time frame: 1 Year
1. Treatment Success is defined as Procedural technical success and absence of aneurysm rupture, conversion to open repair, Type I endoleak after 30 days, Type III endoleak, clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect. 2. Procedural Technical Success is defined as a subject with successful implant. 3. Clinically Significant Device Migration: Core Lab reported aortic stent graft movement >10mm 4. 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). 5. Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery).
11 secondary outcomes
Safety- Number of Major Adverse Events > 30 Days to 5 Years
Time frame: >30 Days to 5 Years
Renal Dysfunction
Time frame: Discharge to 5 Years
Endoleaks
Time frame: 30 Days to 5 Years
Clinical Utility Outcomes
Time frame: At the time of the procedure
Time in ICU
Time frame: In-Hospital
Time to Hospital Discharge
Time frame: Hospital Discharge (Post-Procedure)
Device Patency
Time frame: 30 Days to 5 Years
Device Integrity
Time frame: 30 Days to 5 Years
Aneurysm Sac Morphology
Time frame: 30 Days to 5 Years
Aneurysm Sac Diameter
Time frame: 30 Days to 5 Years
Clinical Utility Outcomes
Time frame: At the time of the procedure
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.
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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 G Clair, MD principal investigator
The Cleveland Clinic
22 sites in 1 country: 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 Abdominal Aortic Aneurysm, run by Endologix at 22 sites 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 13 inclusion and 25 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 22 sites 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.
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?
Safety- Number of Major Adverse Events at 30 Days (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?
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.