Aortic Aneurysm, AbdominalNCT00319475
Evaluation of Mechanical Stapler for Aortic Anastomoses
A study testing AAA or AF/IB (end-to-end) in patients with Leriche Syndrome in people with Aortic Aneurysm, Abdominal and Leriche Syndrome, run by SVSE 2000 Ltd. at 1 site in Germany.
Trial summary
Demonstrate the safety and performance of the Aortic Stapler when used to attach a synthetic graft to an aorta in AAA and Leriche Syndrome patients Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Aortic Aneurysm, Abdominal, Leriche Syndrome
- What is being tested?
- AAA or AF/IB (end-to-end) in patients with Leriche Syndrome
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2006to Jul 2006
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age is between 21 to 85 years old.
- Patient is diagnosed with Abdominal Aortic Aneurysm (AAA) or -aorto-Iliac/Femoral Occlusive Arterial Disease (Leriche' syndrome) by CT-Angio examination and/or angiography examination in patients with Leriche' syndrome.
- Patient with an aneurysm at the neck of the proximal or distal site that is between 5 to 10 mm and with a diameter of 16-22 mm.
- Patient is scheduled for AAA repair
Who cannot join
- Pregnant women
- Active malignancy
- Ruptured aneurysm
- Thoraco-AAA
- Patient with at least one of the following unstable risk factors:
- Renal disease (Cr >2)
Show all 11Show fewer
- Ischemic heart disease (unstable Angina)
- Obstructive Pulmonary Disease (contraindicated for open aortic surgery by respiratory function exam)
- Severe CHF (EF < 25%)
- Patient with known allergy to metals or to the contrast media
- Participation in current or recent (within 60 days prior to surgery) clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Demonstrate the safety and performance of the Aortic Stapler when used to attach a synthetic graft to an aorta in AAA and Leriche Syndrome patients
- Conditions
- Aortic Aneurysm, Abdominal, Leriche Syndrome
- Being tested
- AAA or AF/IB (end-to-end) in patients with Leriche Syndrome
- Medical subject headings
- Aortic Aneurysm, Abdominal, Leriche Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAA or AF/IB (end-to-end) in patients with Leriche SyndromeProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete each stapled anastomosis.
Secondary outcomes (4)
Post-operative follow up:
no leakage
no dilatation
no fistula or hematoma at the anastomotic sites
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startFeb 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- SVSE 2000 Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ralf Kolvenbach, MD, Principal investigator, Augusta Hospital, Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319475
- Sponsor's protocol ID
- EU-DE 006
- Status last verified
- Oct 2006
- First submitted
- 27 Apr 2006
- Last updated
- 11 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mechanical Stapler for Aortic Anastomoses
- ClinicalTrials.gov ID
- NCT00319475
- Acronym / sponsor ID
- EU-DE 006
- Conditions
- Aortic Aneurysm, Abdominal, Leriche Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants
- Lead sponsor
- SVSE 2000 Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2006
- Study completion
- Jul 2006
- First posted
- 27 Apr 2006 (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.
Demonstrate the safety and performance of the Aortic Stapler when used to attach a synthetic graft to an aorta in AAA and Leriche Syndrome patients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient age is between 21 to 85 years old.
- Patient is diagnosed with Abdominal Aortic Aneurysm (AAA) or -aorto-Iliac/Femoral Occlusive Arterial Disease (Leriche' syndrome) by CT-Angio examination and/or angiography examination in patients with Leriche' syndrome.
- Patient with an aneurysm at the neck of the proximal or distal site that is between 5 to 10 mm and with a diameter of 16-22 mm.
- Patient is scheduled for AAA repair
Key exclusion criteria (11 listed)
- Pregnant women
- Active malignancy
- Ruptured aneurysm
- Thoraco-AAA
- Patient with at least one of the following unstable risk factors:
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 |
|---|---|---|
| AAA or AF/IB (end-to-end) in patients with Leriche Syndrome | Procedure or surgery | – |
Primary outcome
Time to complete each stapled anastomosis.
4 secondary outcomes
Post-operative follow up:
no leakage
no dilatation
no fistula or hematoma at the anastomotic sites
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2006.
Related trials for Aortic Aneurysm, Abdominal
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Active, not recruiting
ANEUFIX for Endoleak Type II Repair
Abdominal Aortic Aneurysm, Endoleak
Enrolling by invitation
AneuFix - Prophylactic Sac Filling
Abdominal Aortic Aneurysm, Endoleak
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.
Ralf Kolvenbach, MD principal investigator
Augusta Hospital, Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AAA or AF/IB (end-to-end) in patients with Leriche Syndrome in people with Aortic Aneurysm, Abdominal and Leriche Syndrome, run by SVSE 2000 Ltd. at 1 site in Germany.
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 11 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
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?
Time to complete each stapled anastomosis.. 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 11 Oct 2006; AzTrials last refreshed its copy on 30 Oct 2026.