IN.PACT Global
Research type
Research Study
Full title
The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon.
IRAS ID
115963
Contact name
Randy Schmahl
Contact email
Sponsor organisation
Medtronic, Bakken Research Centre
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 2 months, 30 days
Research summary
Medtronic have released the IN.PACT Admiral™ Drug-Eluting Balloon (DEB)for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions. The DEB is currently being used as part of routine management in a number of European centres, including the United Kingdom.
The purpose of this observational registry is to collate information regarding the longterm effectiveness, safety and performance of the DEB. It is intended to collect data including health related quality of life, from the tools that are
being used routinely in the assessment of these patients.
Approximately 1500 patients will be prospectively enrolled over an planned two year
period.
Approximately 80 centres, mainly from across Europe will participate. Each patient will perform follow up visits according to clinical practice.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
13/NW/0064
Date of REC Opinion
15 Apr 2013
REC opinion
Further Information Favourable Opinion