Complex Abdominal Aortic Aneurysm, ie. Juxtarenal or Suprarenal Aortic Aneurysms, Treated by Fenestrated Endovascular Aortic Aneurysm Repair or Open RepairORFEVARNCT04671732
Cost-utility Analysis of Fenestrated Aortic Stents Versus Open Surgery for the Treatment of Complex Abdominal Aortic Aneurysms
An observational study of Complex Abdominal Aortic Aneurysm, ie. Juxtarenal or Suprarenal Aortic Aneurysms, Treated by Fenestrated Endovascular Aortic Aneurysm Repair or Open Repair, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Introduction: Complex abdominal aortic aneurysms (CAA) are defined as abdominal aneurysms that are anatomically unsuitable for a standard endovascular repair because of a short infrarenal neck or no infrarenal neck. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Abdominal Aortic Aneurysm, ie. Juxtarenal or Suprarenal Aortic Aneurysms, Treated by Fenestrated Endovascular Aortic Aneurysm Repair or Open Repair
- What is being tested?
- Fenestrated endovascular aortic aneurysm repair and open repair of abdominal aortic aneurysm.
- Type of treatment
- Surgery or procedure
- How many people
- 492 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2021to 14 Mar 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with complex AAA (juxtarenal AAA, suprarenal AAA and type IV AAA) needing elective surgical repair (diameter < 50 mm) either by FEVAR or OR. Patients at prohibitive risk for OR are excluded. Patients anatomically unsuitable for FEVAR are also excluded.
Who may be able to join
- Presence of an abdominal aortic aneurysm greater than 50 mm in diameter, anatomically unsuitable for a standard infrarenal stent graft because of an inadequate infrarenal neck and for which a treatment by FEVAR or OR is considered. The AAA can be identified as follows, according to preoperative imaging:
- Short-neck or juxtarenal aneurysm: if treated by OR, would require an infrarenal proximal aortic suture, regardless of the level of clamping.
- Suprarenal aneurysm: if treated by OR, would require a suprarenal/supramesenteric/ supraceliac aortic cross clamping, and a proximal bevelled suture and/or a separate revascularization of at least one renal artery.
- Type IV thoracoabdominal aneurysm: aneurysm extending up to the level of the diaphragm pillars, requiring a supracoeliac clamping with a proximal bevelled suture and/or separate revascularization of at least one renal artery if treated by open surgery.
- Patients aged 18 and over
- Patient who expressed a non-opposition to participating in the study.
- Patient affiliated to the French healyh care system
Who cannot join
- Presence of a type I, II, III or V thoracoabdominal aneurysm according to the modified Crawford Classification.
- Patients for whom an alternative surgical technique is being considered and listes below: laparoscopic aortic repair, hybrid repair, CHIMPS, surgeon modified stent grafting, in situ fenestrations.
- Patients deemed at prohibitive risk for OR :
- uncompensated cardiac failure with LVEF <40% (NYHA class III and IV)
- Coronary revascularization < 1 month
- Large myocardial ischemia >3 segments not revascularized or not revascularizable
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- Non-revascularized or non-revascularizable unstable angina
- Non-operable tight aortic stenosis (mean gradient > 40 mmHg, valve area < 1 cm2, peak transvalvular velocity > 4 m/s)
- Non operable significant mitral shrinkage (area <1.5cm²)
- FEV1 < 50% of the theoretical value
- Home oxygen therapy
- Chronic renal failure with clearance < 30 ml/min
- presence of a main renal artery less than 4 mm in diameter
- Special anatomical configurations: horseshoe kidney, pelvic kidney.
- Lesions of "shaggy" aorta at the visceral segment or at the lower thoracic aorta
- History of abdominal aortic surgery (open or endovascular)
- Dissecting, infected, ruptured or painful aneurysm
- Life expectancy less than 2 years
- Person under judicial protection
- Person under tutorship or curatorship
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, Val De Marne, 94000
About this study
Official title: Cost-utility Analysis of Fenestrated Aortic Stents Versus Open Surgery for the Treatment of Complex Abdominal Aortic Aneurysms: a Prospective Multicenter Comparative Cohort Study
Introduction: Complex abdominal aortic aneurysms (CAA) are defined as abdominal aneurysms that are anatomically unsuitable for a standard endovascular repair because of a short infrarenal neck or no infrarenal neck. These CAAA are usually treated either by fenestrated endovascular aortic repair (FEVAR) or open repair (OR). Data comparing these thechniques remain scarce, mainly consisting of systematic reviews based on retrospective studies. Although mid-term and long-term results remain uncertain, FEVAR has gained widespread acceptance in the vascular community. However, this practice is not evidence base. Beyond clinical results, whether FEVAR is cost-effective or not is not demonstrated. A randomized controlled trial comparing FEVAR and OR is unlikely to be conducted since centers have developed specific expertise and practice, and most of surgeons are not keen to randomize patients. Thus, we believe that a prospective comparative multicentric cohort, with a propensity score and minimization of selection, classification and confusion bias is the most realistic way to provide reliable comparative data on cost effectiveness of FEVAR and OR. Overall, 382 patients are expected to be included (159 in each group).
Objective: The objective of this prospective non-randomized comparative multicenter cohort study is to compare the cost effectiveness incremental ratio at 36 months of FEVAR and OR for CAAA.
Read more
Method: Patients with CAAA discussed for FEVAR or OR in 37 french vascular centers in during a two years inclusion period constitute the population study. Preoperative and postoperative clinical and imaging data will are collected prospectively in eCRF forms. QOL before and after treatment is assessed by the E5D5L. The follow-up period is three years. The primary outcome is the Incremental cost-utility ratio (cost/QALY) at 36 months. We plan to minimize indication biases by using a proposensity score (proposnsity score maching and Inverse probablility of treatment weighting) based on clinical and anatomic characteristics. Patient at prohibitive risk for OR are excluded. Patient anatomically unsuitable for FEVAR are also excluded .
Conclusion: This study should provided valuable data on cost effectiveness of FEVAR for CAAA. Sub-goup analysis will be also conducted.
- Being tested
- Fenestrated endovascular aortic aneurysm repair, open repair of abdominal aortic aneurysm.
- Keywords
- Vascular surgery, Abdominal aortic aneurysm, Juxtarenal aortic aneurysm, Suprarenal aortic aneurysm, Pararenal aortic aneurysm, fenestrated endovascular aortic aneurysm repair, open repair, Cost effectiveness ratio, Cost / utility analysis
- 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.
Fenestrated endovascular aortic aneurysm repairProcedure or surgery
Fenestrated endovascular aortic aneurysm repair consists in excluding a juxtrenal or suprarenal aneurysm by deploying a covered stent (stent graft) in the aorta so as to created sealing zones on both sides of the aneurysm. Since the proximal sealing is located in the visceral segment of the aorta, fenestrations are created to maintain blod flow in renal and visceral arteries. These fenestrations are custom made for each patient. Brindging covered stents are deployed between each fenestration and corresponding target arteries in order to insure sealing of the system.
open repair of abdominal aortic aneurysm.Procedure or surgery
Open repair of abdominal aortic aneurysms consists in cross-clamping the aorta on both sides of the aneurysm and replace the diseased segment by a prosthetic graft.
| Study group | Role | What they receive |
|---|---|---|
| Fenestrated endovascular aortic aneurysm repair (FEVAR) | Not described Receives: Procedure: Fenestrated endovascular aortic aneurysm repair | |
| Open repair (OR) | Not described Receives: Procedure: open repair of abdominal aortic aneurysm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental cost-utility ratio
cost-effectiveness ratio of fenestrated endovascular aortic aneurysm repair (FEVAR) versus Open repair (OR) in the management of complex AAA in real life
Measured: at 36 months post-intervention
Secondary outcomes (2)
Comparison of quality of life after surgery
Comparison of quality of life after FEVAR and OR Quality of life 1 month after surgery,as assessed by EQ5D3L questionnaire
Measured: at 30 days
Comparison of quality of life after surgery
Comparison of quality of life after aortic aneurysm repair or open repair Quality of life 36 months after surgery as assessed by EQ5D3L questionnaire
Measured: at 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start14 Mar 2021
- Primary completion14 Mar 2023
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Abdominal Aortic Aneurysm, ie. Juxtarenal or Suprarenal Aortic Aneurysms, Treated by Fenestrated Endovascular Aortic Aneurysm Repair or Open RepairStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malika Yahmi, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671732
- Sponsor's protocol ID
- APHP200053
- Acronym
- ORFEVAR
- Status last verified
- May 2023
- First submitted
- 11 Dec 2020
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-utility Analysis of Fenestrated Aortic Stents Versus Open Surgery for the Treatment of Complex Abdominal Aortic Aneurysms: a Prospective Multicenter Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT04671732
- Acronym / sponsor ID
- ORFEVAR / APHP200053
- Keywords
- Vascular surgery, Abdominal aortic aneurysm, Juxtarenal aortic aneurysm, Suprarenal aortic aneurysm, Pararenal aortic aneurysm, fenestrated endovascular aortic aneurysm repair, open repair, Cost effectiveness ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 14 Mar 2021 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 17 Dec 2020 (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.
Introduction: Complex abdominal aortic aneurysms (CAA) are defined as abdominal aneurysms that are anatomically unsuitable for a standard endovascular repair because of a short infrarenal neck or no infrarenal neck. These CAAA are usually treated either by fenestrated endovascular aortic repair (FEVAR) or open repair (OR). Data comparing these thechniques remain scarce, mainly consisting of systematic reviews based on retrospective studies. Although mid-term and long-term results remain uncertain, FEVAR has gained widespread acceptance in the vascular community. However, this practice is not evidence base. Beyond clinical results, whether FEVAR is cost-effective or not is not demonstrated. A randomized controlled trial comparing FEVAR and OR is unlikely to be conducted since centers have developed specific expertise and practice, and most of surgeons are not keen to randomize patients. Thus, we believe that a prospective comparative multicentric cohort, with a propensity score and minimization of selection, classification and confusion bias is the most realistic way to provide reliable comparative data on cost effectiveness of FEVAR and OR. Overall, 382 patients are expected to be included (159 in each group).
Objective: The objective of this prospective non-randomized comparative multicenter cohort study is to compare the cost effectiveness incremental ratio at 36 months of FEVAR and OR for CAAA.
Method: Patients with CAAA discussed for FEVAR or OR in 37 french vascular centers in during a two years inclusion period constitute the population study. Preoperative and postoperative clinical and imaging data will are collected prospectively in eCRF forms. QOL before and after treatment is assessed by the E5D5L. The follow-up period is three years. The primary outcome is the Incremental cost-utility ratio (cost/QALY) at 36 months. We plan to minimize indication biases by using a proposensity score (proposnsity score maching and Inverse probablility of treatment weighting) based on clinical and anatomic characteristics. Patient at prohibitive risk for OR are excluded. Patient anatomically unsuitable for FEVAR are also excluded .
Conclusion: This study should provided valuable data on cost effectiveness of FEVAR for CAAA. Sub-goup analysis will be also conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fenestrated endovascular aortic aneurysm repair (FEVAR) | – | Procedure: Fenestrated endovascular aortic aneurysm repair |
| Open repair (OR) | – | Procedure: open repair of abdominal aortic aneurysm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with complex AAA (juxtarenal AAA, suprarenal AAA and type IV AAA) needing elective surgical repair (diameter < 50 mm) either by FEVAR or OR. Patients at prohibitive risk for OR are excluded. Patients anatomically unsuitable for FEVAR are also excluded.
Key inclusion criteria (7 listed)
- Presence of an abdominal aortic aneurysm greater than 50 mm in diameter, anatomically unsuitable for a standard infrarenal stent graft because of an inadequate infrarenal neck and for which a treatment by FEVAR or OR is considered. The AAA can be identified as follows, according to preoperative imaging:
- Patients aged 18 and over
- Patient who expressed a non-opposition to participating in the study.
- Patient affiliated to the French healyh care system
Key exclusion criteria (21 listed)
- Presence of a type I, II, III or V thoracoabdominal aneurysm according to the modified Crawford Classification.
- Patients for whom an alternative surgical technique is being considered and listes below: laparoscopic aortic repair, hybrid repair, CHIMPS, surgeon modified stent grafting, in situ fenestrations.
- Patients deemed at prohibitive risk for OR :
- presence of a main renal artery less than 4 mm in diameter
- Special anatomical configurations: horseshoe kidney, pelvic kidney.
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 |
|---|---|---|
| Fenestrated endovascular aortic aneurysm repairFenestrated endovascular aortic aneurysm repair consists in excluding a juxtrenal or suprarenal aneurysm by deploying a covered stent (stent graft) in the aorta so as to created sealing zones on both sides of the aneurysm. Since the proximal sealing is located in the visceral segment of the aorta, fenestrations are created to maintain blod flow in renal and visceral arteries. These fenestrations are custom made for each patient. Brindging covered stents are deployed between each fenestration and corresponding target arteries in order to insure sealing of the system. | Procedure or surgery | Fenestrated endovascular aortic aneurysm repair (FEVAR) |
| open repair of abdominal aortic aneurysm.Open repair of abdominal aortic aneurysms consists in cross-clamping the aorta on both sides of the aneurysm and replace the diseased segment by a prosthetic graft. | Procedure or surgery | Open repair (OR) |
Primary outcome
Incremental cost-utility ratio
Time frame: at 36 months post-intervention
cost-effectiveness ratio of fenestrated endovascular aortic aneurysm repair (FEVAR) versus Open repair (OR) in the management of complex AAA in real life
2 secondary outcomes
Comparison of quality of life after surgery
Time frame: at 30 days
Comparison of quality of life after surgery
Time frame: at 36 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: No
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.
Malika Yahmi study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Abdominal Aortic Aneurysm, ie. Juxtarenal or Suprarenal Aortic Aneurysms, Treated by Fenestrated Endovascular Aortic Aneurysm Repair or Open Repair, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 21 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: finished, as of the sponsor's last update on 15 May 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incremental cost-utility ratio (time frame: at 36 months post-intervention). 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 15 May 2023; AzTrials last refreshed its copy on 26 Oct 2026.