Iliac AneurysmHYPOGRAFTNCT03312127
Evaluation of Peri-surgical Results at Short and Mean Terms of the GORE ® Excluder Iliac Branch Endoprosthesis
A study testing ILIAC ENDOPROSTHESIS GORE EXCLUDER in people with Iliac Aneurysm, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The aim of this project is to demonstrate the benefit of the use of aortic iliac branch endoprosthesis in the iliac aneurysms and to avoid the classic complications. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Iliac Aneurysm
- What is being tested?
- ILIAC ENDOPROSTHESIS GORE EXCLUDER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2017to 26 Jul 2018
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High surgical risk:
- Comorbidity cardiopulmonary
- Renal insufficiency
- Hostile abdomen including ascites or portal hypertension
- Anatomic criteria:
- Primitive iliac aneurysm superior to 25 mm without collar
Show all 10Show fewer
- Primitive iliac length superior to 40 mm
- Primitive iliac distal diameter superior to 14 mm
- Presence of internal iliac collar
- Affiliation to a social security system
Who cannot join
- Patient without surgical risk
- Non-respect of the Anatomic criteria
- Patient with known allergy to the materials of the device
- Patient with systemic infection
- Patient with severe renal insufficiency
- Patient unable to complete the oximetry test
- Persons under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this project is to demonstrate the benefit of the use of aortic iliac branch endoprosthesis in the iliac aneurysms and to avoid the classic complications.
- Conditions
- Iliac Aneurysm
- Being tested
- ILIAC ENDOPROSTHESIS GORE EXCLUDER
- Medical subject headings
- Iliac Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILIAC ENDOPROSTHESIS GORE EXCLUDERDevice
Set up of GORE ® Excluder Iliac Branch Endoprosthesis in endovascular barring of complex aneurysms without distal neck. In the immediate post-operating follow-up visit and at the 3 months visit and the 12 months visit after surgery, an ultra-sound scan, a tomodensitometric exam and a walking test on a treadmill with oximetric gluteal region exploration will systematically be performed.
| Study group | Role | What they receive |
|---|---|---|
| GORE Excluder | Experimental | GORE Excluder Iliac Branch Endoprosthesis arm with 'ILIAC ENDOPROSTHESIS GORE EXCLUDER' Receives: Device: ILIAC ENDOPROSTHESIS GORE EXCLUDER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion)
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion. It is a binary criterion (permeable or not) This criterion will be evaluated by a doppler ultrasound. These exams will be performed by a unique vascular physician, who will measure the hemodynamic criterions and the associated gluteal region oximetry.
Endoprosthesis will be considered to be permeable if the patient is asymptomatic (absence of gluteal claudication), if Doppler ultrasound and angio-scan confirm the permeability of the endoprosthesis.
Measured: At the immediate post-operating follow-up visit
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion)
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion. It is a binary criterion (permeable or not) This criterion will be evaluated by a doppler ultrasound. These exams will be performed by a unique vascular physician, who will measure the hemodynamic criterions and the associated gluteal region oximetry.
Endoprosthesis will be considered to be permeable if the patient is asymptomatic (absence of gluteal claudication), if Doppler ultrasound and angio-scan confirm the permeability of the endoprosthesis.
Measured: at 3 months after surgery
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion)
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion. It is a binary criterion (permeable or not) This criterion will be evaluated by a doppler ultrasound. These exams will be performed by a unique vascular physician, who will measure the hemodynamic criterions and the associated gluteal region oximetry.
Endoprosthesis will be considered to be permeable if the patient is asymptomatic (absence of gluteal claudication), if Doppler ultrasound and angio-scan confirm the permeability of the endoprosthesis.
Primary permeability will be considered non-maintained at 1 year if a stenosis >70% or a thrombosis of the hypogastric branch is observed by ultra-sound scan at a follow-up visit during the first year after surgery or at a ultra-sound scan exam motivated by pelvic ischemia clinical signs
Measured: at 12 months after surgery
Secondary outcomes (1)
Morbidity
Evaluation of the morbidity:
- Minor events (no revision surgery needed):
- General: pulmonary, cardiologic, renal
- Local: hematoma, false aneurysm, Impaired wound healing
- Major events (revision surgery needed):
- Endoleak
- Thrombosis
- Rupture
Measured: peri-operative, at short term (3 months), mean-term (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start1 Aug 2017
- Primary completion26 Jul 2018
- Study completion26 Jul 2018
Why it stopped: End of inclusion period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliac AneurysmStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre BOSSAVY, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312127
- Sponsor's protocol ID
- 14 7427 15
- Acronym
- HYPOGRAFT
- Status last verified
- Aug 2020
- First submitted
- 27 Jul 2017
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peri-surgical Results at Short and Mean Terms of the GORE ® Excluder Iliac Branch Endoprosthesis
- ClinicalTrials.gov ID
- NCT03312127
- Acronym / sponsor ID
- HYPOGRAFT / 14 7427 15
- Conditions
- Iliac Aneurysm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of inclusion period
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 17 Oct 2017 (actual)
- 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 aim of this project is to demonstrate the benefit of the use of aortic iliac branch endoprosthesis in the iliac aneurysms and to avoid the classic complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GORE Excluder | Experimental | Device: ILIAC ENDOPROSTHESIS GORE EXCLUDERGORE Excluder Iliac Branch Endoprosthesis arm with 'ILIAC ENDOPROSTHESIS GORE EXCLUDER' |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- High surgical risk:
- Anatomic criteria:
- Affiliation to a social security system
Key exclusion criteria (7 listed)
- Patient without surgical risk
- Non-respect of the Anatomic criteria
- Patient with known allergy to the materials of the device
- Patient with systemic infection
- Patient with severe renal insufficiency
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 |
|---|---|---|
| ILIAC ENDOPROSTHESIS GORE EXCLUDERSet up of GORE ® Excluder Iliac Branch Endoprosthesis in endovascular barring of complex aneurysms without distal neck. In the immediate post-operating follow-up visit and at the 3 months visit and the 12 months visit after surgery, an ultra-sound scan, a tomodensitometric exam and a walking test on a treadmill with oximetric gluteal region exploration will systematically be performed. | Device | GORE Excluder |
Primary outcome
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion)
Time frame: At the immediate post-operating follow-up visit
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion. It is a binary criterion (permeable or not) This criterion will be evaluated by a doppler ultrasound. These exams will be performed by a unique vascular physician, who will measure the hemodynamic criterions and the associated gluteal region oximetry. Endoprosthesis will be considered to be permeable if the patient is asymptomatic (absence of gluteal claudication), if Doppler ultrasound and angio-scan confirm the permeability of the endoprosthesis.
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion)
Time frame: at 3 months after surgery
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion. It is a binary criterion (permeable or not) This criterion will be evaluated by a doppler ultrasound. These exams will be performed by a unique vascular physician, who will measure the hemodynamic criterions and the associated gluteal region oximetry. Endoprosthesis will be considered to be permeable if the patient is asymptomatic (absence of gluteal claudication), if Doppler ultrasound and angio-scan confirm the permeability of the endoprosthesis.
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion)
Time frame: at 12 months after surgery
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion. It is a binary criterion (permeable or not) This criterion will be evaluated by a doppler ultrasound. These exams will be performed by a unique vascular physician, who will measure the hemodynamic criterions and the associated gluteal region oximetry. Endoprosthesis will be considered to be permeable if the patient is asymptomatic (absence of gluteal claudication), if Doppler ultrasound and angio-scan confirm the permeability of the endoprosthesis. Primary permeability will be considered non-maintained at 1 year if a stenosis >70% or a thrombosis of the hypogastric branch is observed by ultra-sound scan at a follow-up visit during the first year after surgery or at a ultra-sound scan exam motivated by pelvic ischemia clinical signs
1 secondary outcome
Morbidity
Time frame: peri-operative, at short term (3 months), mean-term (12 months)
Results and safety
The study was stopped early (reason given: End of inclusion period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Jean-Pierre BOSSAVY, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ILIAC ENDOPROSTHESIS GORE EXCLUDER in people with Iliac Aneurysm, run by University Hospital, Toulouse 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 10 inclusion and 7 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: stopped early, as of the sponsor's last update on 26 Aug 2020. 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.
Are results available for this study?
The study was stopped early (reason given: End of inclusion period). 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?
Primary permeability maintenance of the iliac branch endoprosthesis, following its insertion (binary criterion) (time frame: At the immediate post-operating follow-up visit). The study lists 3 primary outcomes in all. 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 Aug 2020.