Nowadays, stenting is became a standard of care in revascularization for superficial femoral artery (SFA) atherosclerotic lesions. However, the Achilles' heel of this technique remains in-stent restenosis (ISR). While most of local therapies have failed to demonstrate significant benefit, studies for the treatment of SFA ISR are lacking and percutaneous transluminal angioplasty remains the current standard of care for this indication. Recent studies have shown successful results of drug eluting balloon in the treatment of SFA de-novo lesions and of coronary ISR. FREERIDE, a French prospective cohort has been set up to evaluate the safety and the efficacy of drug eluting balloon (DEB) for the treatment of SFA atherosclerotic lesions.
Study Type
OBSERVATIONAL
Enrollment
53
Stenting is a standard of care in revascularization for superficial femoral artery (SFA) atherosclerotic lesions. However, the Achilles' heel of this technique remains in-stent restenosis (ISR). While most of local therapies have failed to demonstrate significant benefit, studies for the treatment of SFA ISR are lacking and percutaneous transluminal angioplasty remains the current standard of care for this indication. Recent studies have shown successful results of drug eluting balloon in the treatment of SFA de-novo lesions and of coronary ISR.
Nantes University Hospital
Nantes, France
Target Lesion Revascularization (TLR)
Time frame: at 1 year
Major Adverse Events through
Time frame: at 1 year
Target extremity revascularization (TER)
Time frame: at 1, 3, 6, 9, 12 and 18 months after surgery
clinical improvement equal or above to a stage according to Rutherford classification without superficial femoral artery revascularization
to assess primary maintenance of clinical improvement
Time frame: at 1, 3, 6, 9, 12 and 18 months
peak systolic velocity index without Target Lesion Revascularization
to assess primary patency
Time frame: at 1, 3, 6, 9, 12 and 18 months
Quality of life assessment by EQ5D questionnaire
Time frame: at 1, 3, 6, 9, 12 and 18 mois after surgery
post-angioplasty restenosis
Time frame: at 1, 3, 6, 9, 12 and18 months after surgery
drug relief success without balloon break
Time frame: during surgery
Length of hospitalization stay
Time frame: at 1 year
clinical improvement equal or above to a stage according to Rutherford classification with possible superficial femoral artery surgery
to assess secondary maintenance of clinical improvement
Time frame: at 1, 3, 6, 9, 12 and 18 months
peak systolic velocity index
to assess secondary patency
Time frame: at 1 year
intra-stent restenosis
significant whether restenosis \>50% and peak systolic velocity index \> 2.4
Time frame: at 1, 3, 6, 9, 12 and 18 months after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.