Aortic Aneurysm, AbdominalNCT01698671
InterGard Synergy Post-Marketing Surveillance Study
A study testing InterGard Synergy Vascular Graft in people with Aortic Aneurysm, Abdominal and Occlusive Disease of Artery of Lower Extremity, run by Maquet Cardiovascular at 3 sites in 2 countries.
Trial summary
The purpose of the study is to assess the performance and safety of the InterGard Synergy vascular graft. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Aneurysm, Abdominal, Occlusive Disease of Artery of Lower Extremity
- What is being tested?
- InterGard Synergy Vascular Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2012to May 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients requiring an InterGard Synergy Vascular Graft
Who cannot join
- Patients with contra-indications per InterGard Synergy Vascular Graft
- Patients with current graft infection
- Patients with a known allergy to collagen, triclosan or silver acetate
- Patients who require urgent or emergent surgery
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Study Centers
Frankfurt, Karlsruhe
Study Centers
Heidelberg, Hamburg, Hanau
About this study
The purpose of the study is to assess the performance and safety of the InterGard Synergy vascular graft.
Read the detailed description
Study of the device in patients with aneurysmal and occlusive disease of the abdominal aorta and peripheral arteries.
- Being tested
- InterGard Synergy Vascular Graft
- 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.
InterGard Synergy Vascular GraftDevice
| Study group | Role | What they receive |
|---|---|---|
| InterGard Synergy Vascular Graft | Other | Not described Receives: Device: InterGard Synergy Vascular Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Patency and Complications
- Patency will be assessed by color-coded duplex ultrasound up to 6 months post implantation.
- Complications including the occurrence of graft infections will be assessed up to post implantation.
Measured: 6 months
Secondary outcomes (1)
Mortality rate
Mortality rate will be assessed up to 6 months post implantation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013
- Study completionMay 2014 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maquet Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Max Zegelman, MD, Principal investigator, Krankenhaus Nordwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698671
- Sponsor's protocol ID
- MCV00010173
- Status last verified
- Nov 2013
- First submitted
- 1 Oct 2012
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InterGard Synergy Post-Marketing Surveillance Study
- ClinicalTrials.gov ID
- NCT01698671
- Acronym / sponsor ID
- MCV00010173
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Maquet CardiovascularIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- May 2014 (estimated)
- First posted
- 3 Oct 2012 (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.
The purpose of the study is to assess the performance and safety of the InterGard Synergy vascular graft.
Detailed description
Study of the device in patients with aneurysmal and occlusive disease of the abdominal aorta and peripheral arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| InterGard Synergy Vascular Graft | Other | Device: InterGard Synergy Vascular Graft |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring an InterGard Synergy Vascular Graft
Key exclusion criteria (4 listed)
- Patients with contra-indications per InterGard Synergy Vascular Graft
- Patients with current graft infection
- Patients with a known allergy to collagen, triclosan or silver acetate
- Patients who require urgent or emergent surgery
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 |
|---|---|---|
| InterGard Synergy Vascular Graft | Device | InterGard Synergy Vascular Graft |
Primary outcome
Graft Patency and Complications
Time frame: 6 months
* Patency will be assessed by color-coded duplex ultrasound up to 6 months post implantation. * Complications including the occurrence of graft infections will be assessed up to post implantation.
1 secondary outcome
Mortality rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
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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.
Max Zegelman, MD principal investigator
Krankenhaus Nordwest
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InterGard Synergy Vascular Graft in people with Aortic Aneurysm, Abdominal and Occlusive Disease of Artery of Lower Extremity, run by Maquet Cardiovascular at 3 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 1 inclusion and 4 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 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Austria. 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?
Graft Patency and Complications (time frame: 6 months). 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 26 Nov 2013.