Aneurysmal Disease of the Abdominal AortaPhase 4NCT00824109
Prospective, Multicenter Study of the Second Generation Antimicrobial Graft in the Abdominal Position
A Phase 4 study testing Second Generation Anti-Microbial bifurcated vascular graft (InterGard) in people with Aneurysmal Disease of the Abdominal Aorta and Occlusive Disease of the Abdominal Aorta, run by Datascope Corp. at 1 site in France.
Trial summary
The purpose of this prospective trial is to demonstrate the safety and performance of the Second Generation Anti-Microbial vascular graft in the treatment of aneurysmal and occlusive diseases of the abdominal aorta. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aneurysmal Disease of the Abdominal Aorta, Occlusive Disease of the Abdominal Aorta
- What is being tested?
- Second Generation Anti-Microbial bifurcated vascular graft (InterGard)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2008to Sep 2011
- Phase
- Phase 4
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is 18 - 85 years of age
- Is presenting with an aorto-iliac occlusion (obstruction of flow) or stenosis, or aorto-iliac aneurysm and is eligible for a revascularization with a bifurcated graft
- Is affiliated with a social welfare organization system
- Is willing to participate in the clinical evaluation after signature of the informed consent
- Is able to attend all follow up visits and diagnostics and laboratory exams required by the present protocol
Who cannot join
- Is treated as an emergency
- Is included in another investigation
- Is pregnant or lactating, or a woman of childbearing potential unwillint to use an effective form of contraception for the duration of the trial
- Has a known allergy to the material device used
- Has previous aorto-iliac bypass or replacement
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU La Miletrie, 350 av. Jacques Coeur
86021 Poitiers
Jean-Baptiste Ricco, MD
About this study
Official title: Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in the Abdominal Position
The purpose of this prospective trial is to demonstrate the safety and performance of the Second Generation Anti-Microbial vascular graft in the treatment of aneurysmal and occlusive diseases of the abdominal aorta.
- Being tested
- Second Generation Anti-Microbial bifurcated vascular graft (InterGard)
- Keywords
- Aneurysmal disease of the abdominal aorta, Occlusive disease of the abdominal aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second Generation Anti-Microbial bifurcated vascular graft (InterGard)Device
Also called InterGard
treatment of patients with aorto-iliac occlusion,stenosis, or aneurysm
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study | Other | Consecutive patients meeting the selection criteria Receives: Device: Second Generation Anti-Microbial bifurcated vascular graft (InterGard) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft patency at three years
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startJul 2008
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Disease of the Abdominal AortaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Datascope Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean-Baptiste Ricco, MD, Principal investigator, Vascular Surgery Dept, CHU La Miletrie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824109
- Sponsor's protocol ID
- HR07-001
- Status last verified
- Dec 2010
- First submitted
- 14 Jan 2009
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in the Abdominal Position
- ClinicalTrials.gov ID
- NCT00824109
- Acronym / sponsor ID
- HR07-001
- Keywords
- Aneurysmal disease of the abdominal aorta, Occlusive disease of the abdominal aorta
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Datascope Corp.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 16 Jan 2009 (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 this prospective trial is to demonstrate the safety and performance of the Second Generation Anti-Microbial vascular graft in the treatment of aneurysmal and occlusive diseases of the abdominal aorta.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study | Other | Device: Second Generation Anti-Microbial bifurcated vascular graft (InterGard)Consecutive patients meeting the selection criteria |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is 18 - 85 years of age
- Is presenting with an aorto-iliac occlusion (obstruction of flow) or stenosis, or aorto-iliac aneurysm and is eligible for a revascularization with a bifurcated graft
- Is affiliated with a social welfare organization system
- Is willing to participate in the clinical evaluation after signature of the informed consent
- Is able to attend all follow up visits and diagnostics and laboratory exams required by the present protocol
Key exclusion criteria (5 listed)
- Is treated as an emergency
- Is included in another investigation
- Is pregnant or lactating, or a woman of childbearing potential unwillint to use an effective form of contraception for the duration of the trial
- Has a known allergy to the material device used
- Has previous aorto-iliac bypass or replacement
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 |
|---|---|---|
| Second Generation Anti-Microbial bifurcated vascular graft (InterGard)Also: InterGardtreatment of patients with aorto-iliac occlusion,stenosis, or aneurysm | Device | Single Arm Study |
Primary outcome
Graft patency at three years
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2010.
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Occurrence of Abdominal Aortic Aneurysms in Patients With Aneurysmal Subarachnoid Hemorrhage
Aneurysm Abdominal, Cerebral Aneurysm Ruptured
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.
Jean-Baptiste Ricco, MD principal investigator
Vascular Surgery Dept, CHU La Miletrie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Second Generation Anti-Microbial bifurcated vascular graft (InterGard) in people with Aneurysmal Disease of the Abdominal Aorta and Occlusive Disease of the Abdominal Aorta, run by Datascope Corp. at 1 site in France.
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 5 inclusion and 5 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 3 Dec 2010. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jean-Baptiste Ricco, MD, Professor (00 33 5494438 46, j.b.ricco@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft patency at three years (time frame: three years). 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 3 Dec 2010.