Infrarenal Abdominal Aortic AneurysmNCT00612924
The Vascutek AnacondaTM Stent Graft System Phase II IDE Study
A study testing Anaconda Stent Graft System and Anaconda ONE-LOK Stent Graft System in people with Infrarenal Abdominal Aortic Aneurysm, run by Terumo CVS at 23 sites in 2 countries.
Trial summary
The Phase I safety study is now complete. FDA approval has been granted to proceed to Phase II. The primary objectives of the Phase II study is to assess the safety and effectiveness of the Anaconda Stent Graft System in subjects presenting with abdominal aortic aneurysm (AAA). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Infrarenal Abdominal Aortic Aneurysm
- What is being tested?
- Anaconda Stent Graft System and Anaconda ONE-LOK Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Apr 2009to 13 Jul 2017
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 and ≤ 85 years of age. Females must be non-pregnant, non-lactating, and not planning to become pregnant during the study period
- Females of childbearing potential must use acceptable methods of contraception, be at least one year post-menopausal or be surgically sterile
- Willing and able to comply with the 5 year follow-up period
- Willing to give informed written consent prior to enrollment
- Males with infrarenal AAA ≥ 4.5cm in diameter, or AAA growth ≥ 1.0cm/yr; females with infrarenal AAA ≥ 4.0cm in diameter, or AAA growth ≥ 1.0cm/yr
- Infrarenal AAA with a proximal neck diameter of 16.0 - 31.0mm (Anaconda Stent Graft System)
Show all 13Show fewer
- Infrarenal AAA with a proximal neck diameter of 17.5 - 31.0mm (Anaconda ONE-LOK Stent Graft System)
- Infrarenal AAA with at least 15mm length of non-aneurysm proximal neck
- Infrarenal AAA with an angle of ≤ 60 degrees relative to the long axis of the aneurysm
- Iliac artery distal fixation sites ≥ 20mm in length
- Iliac artery distal fixation site ≤ 21mm in diameter
- Ability to preserve at least one hypogastric artery
- Femoral/iliac artery access vessels, size and morphology should be compatible with the appropriate introducer sheath (18 F, 20 F or 23 F).
Who cannot join
- Pregnant and lactating females or females of childbearing potential unless using acceptable method contraception
- Known sensitivity or allergy to nitinol or polyester
- Known allergy or intolerance of radiopaque contrast agents which cannot be pre-treated
- Thrombus, calcification, and/or plaque ≥ 2mm in thickness and/or ≥ 50% (180 degrees) continuous coverage of the vessel circumference in the intended fixation site
- Irregularly shaped calcification and/or plaque that may compromise the sealing and fixation at the proximal or distal fixation sites
- Ruptured or leaking AAA
Show all 20Show fewer
- Mycotic or inflammatory AAA
- Genetic connective tissue disorder (i.e. Marfans or Ehlers-Danlos syndromes)
- Previous AAA repair
- Requires emergent AAA repair
- Concomitant thoracoabdominal aortic aneurysm
- Active systemic infection
- Myocardial infarction ≤10 weeks prior to procedure
- Aneurysm extends above renal arteries
- Dialysis dependent renal failure or creatinine > 2.5mg/dL
- Significant (>80%) renal artery stenosis not readily treatable
- End-stage chronic obstructive pulmonary disorder
- Patient is clinically and morbidly obese such that the required imaging would be prevented
- Patient has an uncorrectable bleeding abnormality
- Subject has 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
23 sites in 2 countries.
23 sites in 2 countries
United States18 sites
Center for Vascular Awareness
Albany, New York, 12205
Massachusetts General Hospital Vascular and Endovascular Surgery
Boston, Massachusetts, 02114
University of Buffalo surgeons, Inc.
Buffalo, New York, 14203
Michigan Vascular Research Center
Flint, Michigan, 48507
University of Florida
Gainesville, Florida, 32610-0128
Indiana University Vascular Surgery, Methodist Hospital
Indianapolis, Indiana, 46202
Central Arkansas Veteran's Hospital
Little Rock, Arkansas, 72205
Long Beach VA Healthcare System
Long Beach, California, 90822
University of Southern California Healthcare Consultation Ctr. II
Los Angeles, California, 90033-4612
West Los Angeles VA Medical Centre
Los Angeles, California, 90073
Florida Vascular Consultants
Maitland, Florida, 32751
Miller School of Medicine University of Miami
Miami, Florida, 33136
University of Medicine and Dentistry of NJ
New Brunswick, New Jersey, 08903-0019
Vascular and Transplant Specialist
Norfolk, Virginia, 23507
Arizona Heart Institute
Phoenix, Arizona, 85006
Oregon Health and Science University
Portland, Oregon, 97239-3098
Kaiser Permanente Hospital
San Francisco, California, 94115
Southern Illinois Univ. School of Med.
Springfield, Illinois, 62794-9638
Canada5 sites
Peter Lougheed Center
Calgary, Alberta, T1Y 6J4
London Health Science Center
London, Ontario, N6A 5W9
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
St. Clare's Hospital
St. John's, Newfoundland and Labrador, A1C 5B8
Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
Official title: The Anaconda Endovascular Graft US FDA Phase II Clinical Study
The Phase I safety study is now complete. FDA approval has been granted to proceed to Phase II. The primary objectives of the Phase II study is to assess the safety and effectiveness of the Anaconda Stent Graft System in subjects presenting with abdominal aortic aneurysm (AAA). The secondary objectives of this study are to assess additional clinical outcomes measurements associated with treatment of AAA using the Anaconda Stent Graft System
Read the detailed description
Abdominal aortic aneurysms afflict a large number of patients in the United States and world-wide. The treatment of this disorder is based upon the concept of aneurysm repair prior to the presentation of symptoms or rupture. Thus aneurysm repair can be viewed as a prophylactic procedure embarked upon to prevent the disastrous complications of a ruptured aneurysm. The decision to treat an aneurysm electively is based upon a risk to benefit ratio. Treatment options include medical management of co-morbidities (hypertension, pulmonary disease, etc.) with observation of the aneurysm, open surgical aneurysm repair through a transabdominal or retroperitoneal approach, and endovascular aneurysm repair. The decision to intervene is based upon physician judgment. Once the decision to intervene is made, the mode of the intervention must be chosen. Although open surgical repair is more invasive and has been noted to have a higher morbidity and mortality(1;2) than most endovascular reports, few argue with the effectiveness of the procedure. To date, open surgical repair remains the gold standard of care for the aneurysm patient. Endovascular repair has several beneficial characteristics in comparison to an open surgical approach. They include the potential for decreased need for blood transfusions, shorter intensive care unit and total hospital stays, the lack of endotracheal intubation, to name a few. However, the procedure requires adequate imaging prior to graft placement and during the follow-up period, in addition to the availability of a trained team to ensure proper device placement.
- Conditions
- Infrarenal Abdominal Aortic Aneurysm
- Being tested
- Anaconda Stent Graft System, Anaconda ONE-LOK Stent Graft System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anaconda Stent Graft SystemDevice
Endovascular device
Anaconda ONE-LOK Stent Graft SystemDevice
Endovascular device
| Study group | Role | What they receive |
|---|---|---|
| Anaconda | Experimental | Not described Receives: Device: Anaconda Stent Graft System; Device: Anaconda ONE-LOK Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Aneurysm Treatment
defined as a composite endpoint of subjects who have successful delivery and deployment of the Anaconda™ Stent Graft at the initial procedure and at ≤365 days post-procedure and absence of:
- Aneurysm growth ≥ 5 mm as evaluated by the core laboratory
- Post-operative interventions to correct type I or III endoleaks
- Conversion to open surgical repair
- Failed patency of both limbs
- Migration requiring secondary procedure or intervention
- Significant fracture
- Aneurysm rupture
Measured: 365 days
Freedom From Major Adverse Events
The reported values represent the patients that did not experience a Major Adverse Event.
Participants did NOT experience:
- All-Cause Mortality
- Myocardial Infarction (MI)
- Cerebrovascular Accident (CVA)
- Renal Failure
- Respiratory Failure
- Paralysis or Paraplegia, or
- Bowel Ischemia
Measured: 30 days
Secondary outcomes (1)
Secondary Effectiveness, Technical Success
Introduction and deployment of the Stent Graft in the absence of mortality, conversion to surgical repair, failed patency of both limbs, and evidence of a Type I or III endoleak through the first 24 hour post-operative period. The table below indicates the subjects who met the criteria for technical success based on Core Lab imaging evaluations.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startApr 2009
- Primary completionJul 2013
- Study completion13 Jul 2017
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 (2)Papers the sponsor has linked to this study.
- Other trials for Infrarenal 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
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo CVS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vascutek Ltd.
- Responsible party
- Sponsor
- Investigators
- Steven Pregulman, MD, Study director, Terumo Cardiovascular Systems Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612924
- Sponsor's protocol ID
- ANA-006
- Other IDs
- G030036
- Status last verified
- Oct 2017
- First submitted
- 22 Jan 2008
- Last updated
- 16 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Johnston SC, Wilson CB, Halbach VV, Higashida RT, Dowd CF, McDermott MW, Applebury CB, Farley TL, Gress DR. Endovascular and surgical treatment of unruptured cerebral aneurysms: comparison of risks. Ann Neurol. 2000 Jul;48(1):11-9. doi: 10.1002/1531-8249(200007)48:13.3.co;2-m.
PubMed 10894211Greenberg RK, Lawrence-Brown M, Bhandari G, Hartley D, Stelter W, Umscheid T, Chuter T, Ivancev K, Green R, Hopkinson B, Semmens J, Ouriel K. An update of the Zenith endovascular graft for abdominal aortic aneurysms: initial implantation and mid-term follow-up data. J Vasc Surg. 2001 Feb;33(2 Suppl):S157-64. doi: 10.1067/mva.2001.111683.
PubMed 11174829
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anaconda Endovascular Graft US FDA Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT00612924
- Acronym / sponsor ID
- ANA-006
- Conditions
- Infrarenal Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Terumo CVSIndustry (pharma, biotech, devices)
- Collaborators
- Vascutek Ltd.
- Study start
- Apr 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 12 Feb 2008 (estimated)
- Results
- Posted 9 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Phase I safety study is now complete. FDA approval has been granted to proceed to Phase II. The primary objectives of the Phase II study is to assess the safety and effectiveness of the Anaconda Stent Graft System in subjects presenting with abdominal aortic aneurysm (AAA). The secondary objectives of this study are to assess additional clinical outcomes measurements associated with treatment of AAA using the Anaconda Stent Graft System
Detailed description
Abdominal aortic aneurysms afflict a large number of patients in the United States and world-wide. The treatment of this disorder is based upon the concept of aneurysm repair prior to the presentation of symptoms or rupture. Thus aneurysm repair can be viewed as a prophylactic procedure embarked upon to prevent the disastrous complications of a ruptured aneurysm. The decision to treat an aneurysm electively is based upon a risk to benefit ratio. Treatment options include medical management of co-morbidities (hypertension, pulmonary disease, etc.) with observation of the aneurysm, open surgical aneurysm repair through a transabdominal or retroperitoneal approach, and endovascular aneurysm repair. The decision to intervene is based upon physician judgment. Once the decision to intervene is made, the mode of the intervention must be chosen. Although open surgical repair is more invasive and has been noted to have a higher morbidity and mortality(1;2) than most endovascular reports, few argue with the effectiveness of the procedure. To date, open surgical repair remains the gold standard of care for the aneurysm patient. Endovascular repair has several beneficial characteristics in comparison to an open surgical approach. They include the potential for decreased need for blood transfusions, shorter intensive care unit and total hospital stays, the lack of endotracheal intubation, to name a few. However, the procedure requires adequate imaging prior to graft placement and during the follow-up period, in addition to the availability of a trained team to ensure proper device placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anaconda | Experimental | Device: Anaconda Stent Graft System, Device: Anaconda ONE-LOK Stent Graft System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female ≥18 and ≤ 85 years of age. Females must be non-pregnant, non-lactating, and not planning to become pregnant during the study period
- Females of childbearing potential must use acceptable methods of contraception, be at least one year post-menopausal or be surgically sterile
- Willing and able to comply with the 5 year follow-up period
- Willing to give informed written consent prior to enrollment
- Males with infrarenal AAA ≥ 4.5cm in diameter, or AAA growth ≥ 1.0cm/yr; females with infrarenal AAA ≥ 4.0cm in diameter, or AAA growth ≥ 1.0cm/yr
Key exclusion criteria (20 listed)
- Pregnant and lactating females or females of childbearing potential unless using acceptable method contraception
- Known sensitivity or allergy to nitinol or polyester
- Known allergy or intolerance of radiopaque contrast agents which cannot be pre-treated
- Thrombus, calcification, and/or plaque ≥ 2mm in thickness and/or ≥ 50% (180 degrees) continuous coverage of the vessel circumference in the intended fixation site
- Irregularly shaped calcification and/or plaque that may compromise the sealing and fixation at the proximal or distal fixation sites
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 |
|---|---|---|
| Anaconda Stent Graft SystemEndovascular device | Device | Anaconda |
| Anaconda ONE-LOK Stent Graft SystemEndovascular device | Device | Anaconda |
Primary outcome
Successful Aneurysm Treatment
Time frame: 365 days
defined as a composite endpoint of subjects who have successful delivery and deployment of the Anaconda™ Stent Graft at the initial procedure and at ≤365 days post-procedure and absence of: * Aneurysm growth ≥ 5 mm as evaluated by the core laboratory * Post-operative interventions to correct type I or III endoleaks * Conversion to open surgical repair * Failed patency of both limbs * Migration requiring secondary procedure or intervention * Significant fracture * Aneurysm rupture
Freedom From Major Adverse Events
Time frame: 30 days
The reported values represent the patients that did not experience a Major Adverse Event. Participants did NOT experience: * All-Cause Mortality * Myocardial Infarction (MI) * Cerebrovascular Accident (CVA) * Renal Failure * Respiratory Failure * Paralysis or Paraplegia, or * Bowel Ischemia
1 secondary outcome
Secondary Effectiveness, Technical Success
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10894211Johnston SC, Wilson CB, Halbach VV, Higashida RT, Dowd CF, McDermott MW, Applebury CB, Farley TL, Gress DR. Endovascular and surgical treatment of unruptured cerebral aneurysms: comparison of risks. Ann Neurol. 2000 Jul;48(1):11-9. doi: 10.1002/1531-8249(200007)48:13.3.co;2-m.
- Background: PubMed 11174829Greenberg RK, Lawrence-Brown M, Bhandari G, Hartley D, Stelter W, Umscheid T, Chuter T, Ivancev K, Green R, Hopkinson B, Semmens J, Ouriel K. An update of the Zenith endovascular graft for abdominal aortic aneurysms: initial implantation and mid-term follow-up data. J Vasc Surg. 2001 Feb;33(2 Suppl):S157-64. doi: 10.1067/mva.2001.111683.
- Company websiteLink provided by the sponsor.
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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.
Steven Pregulman, MD study director
Terumo Cardiovascular Systems Corporation
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anaconda Stent Graft System and Anaconda ONE-LOK Stent Graft System in people with Infrarenal Abdominal Aortic Aneurysm, run by Terumo CVS at 23 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 13 inclusion and 20 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 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada. 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 9 Mar 2016). 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?
Successful Aneurysm Treatment (time frame: 365 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 NCT00612924, which also lists 2 linked publications.
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 Oct 2017.