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

University of Pisa150 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

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

Interventions

Intravascular litothripsy (IVL)DEVICE

endovascular treatment of primary common femoral artery atherosclerotic disease with intravascular litothripsy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Pisa

Pisa, Italy

RECRUITING

Outcomes

Primary Outcomes

Technical success

insertion/use of the device after crossing the steno-obstructive lesion and its removal without complications, restoration of vessel patency in the absence of stenosis/acute recoil \>30%, rupture/perforation of the common femoral artery, need for a bailout stenting

Time frame: Intraprocedural

Clinical success

absence of intraprocedural complications including distal embolization and improvement of at least 1 Rutherford class assessed 1 month after the procedure

Time frame: Intraprocedural / 1 month

Primary patency

patency of the treated vessel in the absence of a restenosis \>30%