Cost-utility Analysis of the Outpatient Versus Conventional Hospitalization in Treatment of Occlusive Arterial Disease
AMBUVASC
2 other identifiers
interventional
160
1 country
11
Brief 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. Patients referred for peripheral arterial disease (PAD) will be randomized in two arms and a 3 months follow-up will be performed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2016
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2015
CompletedFirst Posted
Study publicly available on registry
October 20, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedNovember 6, 2019
November 1, 2019
1.5 years
October 19, 2015
November 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months
Secondary Outcomes (4)
Budget impact analysis
5 years
Complication rates
1 month
Functional improvement
1 month
Time period to back-to-work
1 month
Study Arms (2)
Outpatient hospitalisation
OTHERThe 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
OTHERThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Radial or brachial puncture
- Antegrade femoral puncture
- Contraindication to endovascular treatment
- Less than one month life expectancy
- Participation in another clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nantes University Hospitallead
- Ministry of Health, Francecollaborator
Study Sites (11)
Besançon University Hospital
Besançon, France
Colmar Hospital
Colmar, France
Dijon University Hospital
Dijon, France
Clinique de Fontaine
Fontaine-lès-Dijon, France
La Roche sur Yon Hospital
La Roche-sur-Yon, France
Marseille University Hospital (La Timone)
Marseille, France
Marseille University Hospital (North)
Marseille, France
Nantes University Hospital
Nantes, France
Rennes University Hospital
Rennes, France
Rouen Clinique de l'Europe
Rouen, France
Saint-Etienne University Hospital
Saint-Etienne, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yann Gouëffic, Md., PhD.
University Hospital of Nantes, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2015
First Posted
October 20, 2015
Study Start
February 1, 2016
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
November 6, 2019
Record last verified: 2019-11