Peripheral Arterial Disease
Conditions
Keywords
Superficial femoral artery, endovascular, Drug eluting balloon, Paclitaxel
Brief summary
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.
Interventions
PROCEDUREPacLitaxel Eluting Balloon Application
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.
Sponsors
Nantes University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years old * Symptomatic patient according to Rutherford Class 1, 2, 3, 4 or 5 * Clinical degradation by at least 1 Rutherford stage or absence of healing of all skin lesions * Symptoms related to SFA ISR defined by PSVR \> 2.4 within 3 to 24 months after SFA stenting of de novo atherosclerotic lesions. Each patient may have either one or both limbs treated in the study * The target ISR lesion is fully comprised between the origin of the SFA and distally the femoropopliteal crossover (crossing by SFA of medial rim of femur in the PA projection) * Adequate SFA inflow and outflow either pre-existing or successfully re-established (outflow defined as patency of at least one infragenicular artery) * The target lesion must no extend beyond the stent margin * Successful crossing of the target lesion, inflow and outflow lesions with a guidewire * Patient belongs to the French health care system * Written informed consent
Exclusion criteria
* No atheromatous disease * Asymptomatic lesion * Known allergies to heparin, aspirin, other anti-coagulant/antiplatelet therapies, and/or paclitaxel * Acute limb ischemia * Patient on oral anticoagulation therapy * Target lesion requires / has been pre-treated with alternative therapy such as: DES, laser, atherectomy, cryoplasty, cutting/scoring balloon, etc. * Life expectancy \< 1 year * Patient involved in another trial * Refusing patient * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Revascularization (TLR) | at 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target extremity revascularization (TER) | 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 | at 1, 3, 6, 9, 12 and 18 months | to assess primary maintenance of clinical improvement |
| peak systolic velocity index without Target Lesion Revascularization | at 1, 3, 6, 9, 12 and 18 months | to assess primary patency |
| Quality of life assessment by EQ5D questionnaire | at 1, 3, 6, 9, 12 and 18 mois after surgery | — |
| post-angioplasty restenosis | at 1, 3, 6, 9, 12 and18 months after surgery | — |
| Major Adverse Events through | at 1 year | — |
| Length of hospitalization stay | at 1 year | — |
| clinical improvement equal or above to a stage according to Rutherford classification with possible superficial femoral artery surgery | at 1, 3, 6, 9, 12 and 18 months | to assess secondary maintenance of clinical improvement |
| peak systolic velocity index | at 1 year | to assess secondary patency |
| intra-stent restenosis | at 1, 3, 6, 9, 12 and 18 months after surgery | significant whether restenosis \>50% and peak systolic velocity index \> 2.4 |
| drug relief success without balloon break | during surgery | — |
Countries
France
Outcome results
None listed