AAA Graft Implant for Primary Aneurysm TreatmentEndoRefixNCT00668681
Evaluation of EndoRefix Endovascular Delivery System and Staple
A study testing EndoRefix in people with AAA Graft Implant for Primary Aneurysm Treatment and AAA Graft Repair to Extend Life of Implant, run by Lombard Medical at 7 sites in United States.
Trial summary
This study is intended to provide data to verify safe delivery of a staple previously intended for use in open surgical procedures. A newly modified delivery system will provide endovascular access for implantation of a staple during endovascular graft procedures. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- AAA Graft Implant for Primary Aneurysm Treatment, AAA Graft Repair to Extend Life of Implant
- What is being tested?
- EndoRefix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2008to Feb 2009
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female >21 years of age
- Undergoing endovascular stent grafting for AAA repair
- Post endovascular stent grafting where stent stabilization is necessary due to stent fixation failure and/or persistent endoleak.
Who cannot join
- Pregnant
- Religious, cultural or other objection to the receipt of blood, or blood products.
- Unwilling to comply with follow-up schedule
- Unwillingness, or inability to provide informed consent to both trila and procedure
- Ruptured Aneurysm
- Area where staple is to be placed has significant loose thrombus associated with it
Show all 15Show fewer
- Acute or chronic aortic dissection or mycotoc aneurysm
- Allergy to device materials
- Allergy to or intolerance to use of contrast media or cannot be exposed to suitable remedial treatment such as steroids and/or diphenhydramine.
- Clinically and morbidly obese such that imaging would be severely adversely affected.
- Uncorrectable bleeding abnormality
- Inflammatory aneurysm
- Connective tissue disease (e.g., Marfans syndrome, Ehlers Danlos syndrome)
- Patients with PTFE grafts
- Patients with investigational grafts (i.e., those grafts that are not FDA approved)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Emory University Hospital
Atlanta, Georgia, 30368
University of Alabama Birmingham
Birmingham, Alabama, 35294
St. Paul University Hospital
Dallas, Texas, 75390
St. Lukes Episcopal Hospital
Houston, Texas, 77030
Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire, 03756
Mount Sinai Hospital
New York, New York, 10021
Arizona Heart Hospital
Phoenix, Arizona, 85006
About this study
Official title: Safety Data Collection for Delivery System and Use of Staple in Endovascular Procedures
This study is intended to provide data to verify safe delivery of a staple previously intended for use in open surgical procedures. A newly modified delivery system will provide endovascular access for implantation of a staple during endovascular graft procedures.
- Conditions
- AAA Graft Implant for Primary Aneurysm Treatment, AAA Graft Repair to Extend Life of Implant
- Being tested
- EndoRefix
- Keywords
- Abdominal Aortic Aneurysm
- 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.
EndoRefixDevice
| Study group | Role | What they receive |
|---|---|---|
| Endorefix | Active comparator | Evaluation of EndoRefix Endovascular Delivery System and Staple Receives: Device: EndoRefix |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2008
- Study completionFeb 2009 (estimated)
Why it stopped: Company business decision, IDE closed, no commercialization planned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AAA Graft Implant for Primary Aneurysm TreatmentStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lombard Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Arko, MD, Study chair, St. Paul University Hospital, Dallas TexasPeter Faries, MD, Principal investigator, Mount Sinai Hospital, New YorkLouis Sanchez, MD, Principal investigator, Barnes Jewish Hospital, St. Louis MissouriVenkatash Ramaiah, MD, Principal investigator, Arizona Heart Institute, Phoenix, ArizonaMark Mewissen, MD, Principal investigator, St. Luke's Medical CenterMark Fillinger, MD, Principal investigator, Mary Hitchcock Memorial Hospital, Lebanon New HampshireZvonko Krajcer, MD, Principal investigator, St. Lukes Episcopal Hospital, Houston TexasWill Jordan, MD, Principal investigator, University of Alabama, Birmingham Alabama.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668681
- Sponsor's protocol ID
- Endo060234
- Acronym
- EndoRefix
- Status last verified
- Oct 2012
- First submitted
- 25 Apr 2008
- Last updated
- 17 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Data Collection for Delivery System and Use of Staple in Endovascular Procedures
- ClinicalTrials.gov ID
- NCT00668681
- Acronym / sponsor ID
- EndoRefix / Endo060234
- Conditions
- AAA Graft Implant for Primary Aneurysm Treatment, AAA Graft Repair to Extend Life of Implant
- Keywords
- Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company business decision, IDE closed, no commercialization planned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lombard MedicalIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (estimated)
- First posted
- 29 Apr 2008 (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.
This study is intended to provide data to verify safe delivery of a staple previously intended for use in open surgical procedures. A newly modified delivery system will provide endovascular access for implantation of a staple during endovascular graft procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endorefix | Active comparator | Device: EndoRefixEvaluation of EndoRefix Endovascular Delivery System and Staple |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female >21 years of age
- Undergoing endovascular stent grafting for AAA repair
- Post endovascular stent grafting where stent stabilization is necessary due to stent fixation failure and/or persistent endoleak.
Key exclusion criteria (15 listed)
- Pregnant
- Religious, cultural or other objection to the receipt of blood, or blood products.
- Unwilling to comply with follow-up schedule
- Unwillingness, or inability to provide informed consent to both trila and procedure
- Ruptured Aneurysm
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 |
|---|---|---|
| EndoRefix | Device | Endorefix |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2012.
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.
Frank Arko, MD study chair
St. Paul University Hospital, Dallas Texas
Peter Faries, MD principal investigator
Mount Sinai Hospital, New York
Louis Sanchez, MD principal investigator
Barnes Jewish Hospital, St. Louis Missouri
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoRefix in people with AAA Graft Implant for Primary Aneurysm Treatment and AAA Graft Repair to Extend Life of Implant, run by Lombard Medical at 7 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 3 inclusion and 15 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: withdrawn, as of the sponsor's last update on 17 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 17 Oct 2012.