Endovascular Treatment of Primary Common FEmoral Artery atheroSclerotic Disease wiTh IntraVAscular Litothripsy (FESTIVAL)

University of Pisa

Status: Enrolling

Conditions: Critical Limb-Threatening Ischemia; Common Femoral Artery Occlusion; Common Femoral Artery Stenosis; Peripheral Arterial Disease

Treatments: Device: Intravascular litothripsy (IVL)

Study type: Observational

Funder types: Other

Identifiers

NCT05821829

FESTIVAL

Details and patient eligibility

About

Prospective, nonrandomized, multicenter, national, multidisciplinary, real-world data collection with the aim to evaluate the short-term safety and efficacy of intravascular lithotripsy in the treatment of steno-obstructive disease of the common femoral artery

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with peripheral arterial disease (Rutherford class 3-6)
2. Presence of a steno-obstructive lesion of the common femoral artery (Azema classification 1-3)
3. Possible endovascular treatment of both the iliac axis and/or femoro-distal vessels
4. Possible post-dilatation with plain or drug-coated balloon angioplasty

Exclusion criteria

1. Concomitant open surgery (ilio-femoral or femoro-distal bypass)
2. Presence of a steno-obstructive lesion of the common femoral artery in previous open surgery (Azema classification 4)
3. Presence of a steno-obstructive lesion of the common femoral artery after a previous endovascular procedure