The REGAL study is a European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing additional data including health economics data to support the use of the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries.
A European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing additional data including health economics data to support the use of the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries. The objective of the study is to collect additional data including health economics data to support the use of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions.
Study Type
OBSERVATIONAL
Enrollment
291
stent implantation during the index procedure
Medizinische Universität Graz
Graz, Austria
ZOL Genk
Genk, Limburg, Belgium
Health care costs
Health care costs at index procedure and changes in health care costs from baseline
Time frame: Index Procedure, 1, 6, 12 and 24 months
Quality of Life Improvement
Change in EQ-5D-5L™ from baseline
Time frame: 1, 6, 12 and 24 months
Walking Improvement
Change in Walking Impairment Questionnaire (WIQ) from baseline
Time frame: 1, 6, 12 and 24 months
Rate of Primary and Secondary Sustained Clinical Improvement
Changes in Rutherford Classification from baseline
Time frame: 1, 6, 12 and 24 months
Rate of Hemodynamic Improvement
Changes in in Ankle-Brachial Index (ABI) from baseline
Time frame: 1, 6, 12 and 24 months
Health care utilization
Changes in healthcare utilization over time
Time frame: 1, 6, 12 and 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, Vlaams-Brabant, Belgium
CHU Sart Tilman
Liège, Belgium
Centre Hospitalier Universitaire Grenoble-Alpes
Grenoble, France
Clinique Parly II
Le Chesnay, France
ASL Asti
Asti, Italy
Policlinico Vittorio Emanuele
Catania, Italy
Policlinico di Monza
Monza, Italy
Policlinico Umberto I
Roma, Italy
...and 13 more locations