Peripheral Arterial DiseaseAMBUVASCNCT02581150
Cost-utility Analysis of the Outpatient Versus Conventional Hospitalization in Treatment of Occlusive Arterial Disease
A study testing Treatment of Occlusive Arterial Disease in people with Peripheral Arterial Disease, run by Nantes University Hospital at 11 sites in France.
Trial summary
The purpose of this study is to assess the efficiency of outpatient surgery compared to conventional hospitalization in endovascular treatment of occlusive arterial disease. A cost-utility analysis will be conducted from a societal perspective. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Treatment of Occlusive Arterial Disease
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 11 sitesFrance
- Study dates
- Feb 2016to Aug 2017
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients limping
- Patients with PAD requiring endovascular management
- Patients with stabilized level 1 to 3 ASA (classification of the American Society of Anesthesiology)
- Ability to walking
- Endovascular indicated and compatible with an introducer 5F to 7F
- Agreeing to participate in the study and having signed an informed consent.
- Agreeing to lend itself to a post-operative monitoring a duration of 30 days
- Social Insured
Who cannot join
- No possibility of an outpatient management
- Previous participation in the AMBUVASC study
- Refusal of patient to participate in the study
- Patient with hemostasis disorders
- Acute Ischemia
- Using a more 7F introducer
Show all 11Show fewer
- Radial or brachial puncture
- Antegrade femoral puncture
- Contraindication to endovascular treatment
- Less than one month life expectancy
- Participation in another clinical trial
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Besançon University Hospital
Besançon
Colmar Hospital
Colmar
Dijon University Hospital
Dijon
Clinique de Fontaine
Fontaine-lès-Dijon
La Roche sur Yon Hospital
La Roche-sur-Yon
Marseille University Hospital (La Timone)
Marseille
Marseille University Hospital (North)
Marseille
Nantes University Hospital
Nantes
Rennes University Hospital
Rennes
Rouen Clinique de l'Europe
Rouen
Saint-Etienne University Hospital
Saint-Etienne
About this study
Official title: Cost-utility Analysis of the Outpatient Hospitalization Versus Conventional Hospitalization in Endovascular Treatment of Occlusive Arterial Disease
The purpose of this study is to assess the efficiency of outpatient surgery compared to conventional hospitalization in endovascular treatment of occlusive arterial disease. A cost-utility analysis will be conducted from a societal perspective. Patients referred for peripheral arterial disease (PAD) will be randomized in two arms and a 3 months follow-up will be performed.
Read the detailed description
Rationale for ambulatory hospitalization is based on increased demand of hospital care, hospital budgets constraints and patients who ask for a prompt recovery. Consequently, physicians should find ways to optimize the resources' allocation, without compromising quality, safety and efficiency of patient care. Several studies and routine practice have shown that ambulatory hospitalization was safe but we are still lacking evidence to demonstrate the cost-utility of this kind of management.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Treatment of Occlusive Arterial Disease
- Keywords
- Outpatient hospitalization, Randomized trial, Peripheral arterial disease, Endovascular treatment, Health Economics
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of Occlusive Arterial DiseaseProcedure or surgery
Regarding the intervention, the technique used during the diagnostic and/or therapeutic procedure shall be left to the operator's discretion, except the use of an arterial closure device (ACD). In the ambulatory hospitalisation arm, the ACD use will be mandatory. In the conventional hospitalisation arm, ACD will be used at the discretion of the interventionalist.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient hospitalisation | Other | The intervention is the Treatment of Occlusive Arterial Disease, during an ambulatory hospitalisation, with the use of an arterial closure device (ACD).
The patients treated for PAD (Peripheral Arterial Disease) are informed and prepared in the morning of D0. The surgical endovascular procedure is performed at D0 before 1:00 p.m. The patients leave the hospital in the evening at D0 after a systematic visit. Receives: Procedure: Treatment of Occlusive Arterial Disease |
| Conventional inpatient hospitalisation | Other | The intervention is the Treatment of Occlusive Arterial Disease, during a conventional hospitalisation, with or without ACD (ACD will be used at the discretion of the interventionalist).
The patients treated for PAD arrive at the hospital the day before surgery (D-1). The surgical endovascular procedure takes place the next day (D0). The day after (D1), the patients leave the hospital after a systematic visit. Receives: Procedure: Treatment of Occlusive Arterial Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Cost Effectiveness Ratio (ICER) comparing cost and utility in the two arms
The objective of the study is to perform a cost-utility analysis comparing outpatient surgery to conventional hospitalization in endovascular treatment of occlusive arterial disease. The analysis will be conducted from a society's perspective using a one-month time horizon following the date of intervention (and 2 months before intervention). A microcosting approach will be used to estimate the cost of the surgical intervention in both arms and all subsequent in-hospital and ambulatory care resources consumption will be systematically recorded during the one month follow-up period. Effectiveness will be assessed in terms of Quality-Adjusted Life-Years (QALYs) estimated from patients' answers to the Euroqol EQ-5D questionnaire and french preferences scores. Results will be presented as an incremental cost-per-QALY ratio.
Measured: 3 months
Secondary outcomes (4)
Budget impact analysis
The budget impact analysis will estimate the net financial profit (the difference between the costs incurred and profits obtained, or avoided costs) in developing the ambulatory surgery in the management of PAD. The perspective adopted will be that of the health care facilities and of the National health insurance. This analysis will be conducted in a 5 years time horizon to consider a full exploitation of the potential for substitution between conventional hospitalisation and ambulatory hospitalisation for eligible patients.
Measured: 5 years
Complication rates
The major vascular complications that can occur within 30 days are: Complications Intraoperative, Hematoma, Bleeding from the groin, arteriovenous fistula, Pseudo aneurysm, retroperitoneal hemorrhage, Critical Ischemia, Infection, Thrombosis.
Measured: 1 month
Functional improvement
The assessment of the functional improvement will be performed with Rutherford Classification.
Measured: 1 month
Time period to back-to-work
The time period to back-to-work will be assessed through the measurement of the duration of sick leave for people who work.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startFeb 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Yann Gouëffic, Md., PhD., Principal investigator, University Hospital of Nantes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581150
- Sponsor's protocol ID
- RC15_0044
- Other IDs
- PRME-14-0444
- Acronym
- AMBUVASC
- Status last verified
- Nov 2019
- First submitted
- 19 Oct 2015
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goueffic Y, Pin JL, Sabatier J, Alimi Y, Steinmetz E, Magnan PE, Marret O, Kaladji A, Chavent B, Kretz B, Jobert A, Schirr-Bonnans S, Guyomarc'h B, Riche VP, du Mont LS, Tessier P. Editor's Choice - A Cost Effectiveness Analysis of Outpatient versus Inpatient Hospitalisation for Lower Extremity Arterial Disease Endovascular Revascularisation in France: A Randomised Controlled Trial. Eur J Vasc Endovasc Surg. 2021 Mar;61(3):447-455. doi: 10.1016/j.ejvs.2020.11.030. Epub 2021 Jan 5.
PubMed 33414066
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-utility Analysis of the Outpatient Hospitalization Versus Conventional Hospitalization in Endovascular Treatment of Occlusive Arterial Disease
- ClinicalTrials.gov ID
- NCT02581150
- Acronym / sponsor ID
- AMBUVASC / RC15_0044
- Conditions
- Peripheral Arterial Disease
- Keywords
- Outpatient hospitalization, Randomized trial, Peripheral arterial disease, Endovascular treatment, Health Economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Feb 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 20 Oct 2015 (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 study is to assess the efficiency of outpatient surgery compared to conventional hospitalization in endovascular treatment of occlusive arterial disease. A cost-utility analysis will be conducted from a societal perspective. Patients referred for peripheral arterial disease (PAD) will be randomized in two arms and a 3 months follow-up will be performed.
Detailed description
Rationale for ambulatory hospitalization is based on increased demand of hospital care, hospital budgets constraints and patients who ask for a prompt recovery. Consequently, physicians should find ways to optimize the resources' allocation, without compromising quality, safety and efficiency of patient care. Several studies and routine practice have shown that ambulatory hospitalization was safe but we are still lacking evidence to demonstrate the cost-utility of this kind of management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient hospitalisation | Other | Procedure: Treatment of Occlusive Arterial DiseaseThe intervention is the Treatment of Occlusive Arterial Disease, during an ambulatory hospitalisation, with the use of an arterial closure device (ACD). The patients treated for PAD (Peripheral Arterial Disease) are informed and prepared in the morning of D0. The surgical endovascular procedure is performed at D0 before 1:00 p.m. The patients leave the hospital in the evening at D0 after a systematic visit. |
| Conventional inpatient hospitalisation | Other | Procedure: Treatment of Occlusive Arterial DiseaseThe intervention is the Treatment of Occlusive Arterial Disease, during a conventional hospitalisation, with or without ACD (ACD will be used at the discretion of the interventionalist). The patients treated for PAD arrive at the hospital the day before surgery (D-1). The surgical endovascular procedure takes place the next day (D0). The day after (D1), the patients leave the hospital after a systematic visit. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients limping
- Patients with PAD requiring endovascular management
- Patients with stabilized level 1 to 3 ASA (classification of the American Society of Anesthesiology)
- Ability to walking
- Endovascular indicated and compatible with an introducer 5F to 7F
Key exclusion criteria (11 listed)
- No possibility of an outpatient management
- Previous participation in the AMBUVASC study
- Refusal of patient to participate in the study
- Patient with hemostasis disorders
- Acute Ischemia
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 |
|---|---|---|
| Treatment of Occlusive Arterial DiseaseRegarding the intervention, the technique used during the diagnostic and/or therapeutic procedure shall be left to the operator's discretion, except the use of an arterial closure device (ACD). In the ambulatory hospitalisation arm, the ACD use will be mandatory. In the conventional hospitalisation arm, ACD will be used at the discretion of the interventionalist. | Procedure or surgery | Conventional inpatient hospitalisation, Outpatient hospitalisation |
Primary outcome
Incremental Cost Effectiveness Ratio (ICER) comparing cost and utility in the two arms
Time frame: 3 months
The objective of the study is to perform a cost-utility analysis comparing outpatient surgery to conventional hospitalization in endovascular treatment of occlusive arterial disease. The analysis will be conducted from a society's perspective using a one-month time horizon following the date of intervention (and 2 months before intervention). A microcosting approach will be used to estimate the cost of the surgical intervention in both arms and all subsequent in-hospital and ambulatory care resources consumption will be systematically recorded during the one month follow-up period. Effectiveness will be assessed in terms of Quality-Adjusted Life-Years (QALYs) estimated from patients' answers to the Euroqol EQ-5D questionnaire and french preferences scores. Results will be presented as an incremental cost-per-QALY ratio.
4 secondary outcomes
Budget impact analysis
Time frame: 5 years
Complication rates
Time frame: 1 month
Functional improvement
Time frame: 1 month
Time period to back-to-work
Time frame: 1 month
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 14 Sep 2026.
- Results publication: PubMed 33414066Goueffic Y, Pin JL, Sabatier J, Alimi Y, Steinmetz E, Magnan PE, Marret O, Kaladji A, Chavent B, Kretz B, Jobert A, Schirr-Bonnans S, Guyomarc'h B, Riche VP, du Mont LS, Tessier P. Editor's Choice - A Cost Effectiveness Analysis of Outpatient versus Inpatient Hospitalisation for Lower Extremity Arterial Disease Endovascular Revascularisation in France: A Randomised Controlled Trial. Eur J Vasc Endovasc Surg. 2021 Mar;61(3):447-455. doi: 10.1016/j.ejvs.2020.11.030. Epub 2021 Jan 5.
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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.
Yann Gouëffic, Md., PhD. principal investigator
University Hospital of Nantes, France
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of Occlusive Arterial Disease in people with Peripheral Arterial Disease, run by Nantes University Hospital at 11 sites 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 8 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: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 Effectiveness Ratio (ICER) comparing cost and utility in the two arms (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02581150, which also lists 1 linked publication.
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 14 Sep 2026.