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Cost-utility Analysis of the Outpatient Versus Conventional Hospitalization in Treatment of Occlusive Arterial Disease

NCT02581150 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2019-11-06

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Disease

Interventions

PROCEDURE

Treatment of Occlusive Arterial Disease

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.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Yann Gouëffic, Md., PhD. · University Hospital of Nantes, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02581150 on ClinicalTrials.gov