Martinsen 2015.
Study name | Economic study design for the optimise study on orbital atherectomy and drug‐coated balloon devices for the treatment of below‐the‐knee peripheral arterial disease |
Methods | Prospective, multicentre, randomised, postmarket pilot study |
Participants | Country: Germany, Switzerland and Austria No of participants: 50 |
Interventions |
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Outcomes | Health economic outcomes will be measured at the index procedure, at 30 days, three months, six months, 12 months, and 24 months postprocedure for the treatment of PAD and its complications (repeat procedures, amputations, etc.). Health‐related quality of life will be measured using the EQ‐5D instrument. Resource utilization will be collected from case report forms and hospital accounting systems, using site‐specific procedure code information of relevant German, Swiss, and Austrian sites. Analyses from the third‐party payer perspective will be informed by country‐specific reimbursement amounts, using Germany as the initial reference case. Resulting cost difference and incremental cost‐effectiveness are the main economic outcomes targeted in this analysis |
Starting date | Unknown |
Contact information | Unknown |
Notes | Published need for paper but no results available |