Common Femoral Artery Occlusion, Common Femoral Artery Stenosis, Critical Limb-Threatening Ischemia, Peripheral Arterial Disease
Conditions
Brief summary
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
Interventions
DEVICEIntravascular litothripsy (IVL)
endovascular treatment of primary common femoral artery atherosclerotic disease with intravascular litothripsy
Sponsors
University of Pisa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically driven freedom from target lesion restenosis (cdTLR) | 1 month / 6 months / 1 year | restenosis resulting in vessel occlusion or stenosis with maximum PSV \> 2.5 m/sec |
| Primary patency | 1 month / 6 months / 1 year | patency of the treated vessel in the absence of a restenosis \>30% |
| Primary assisted patency | 1 month / 6 months / 1 year | patency of the treated vessel after one or more endovascular reinterventions |
| Secondary patency | 1 month / 6 months / 1 year | patency of the treated vessel after occlusione and treatment by surgical or endovascular means |
| Technical success | Intraprocedural | 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 |
| Clinical success | Intraprocedural / 1 month | absence of intraprocedural complications including distal embolization and improvement of at least 1 Rutherford class assessed 1 month after the procedure |
Secondary
| Measure | Time frame |
|---|---|
| Patency of profunda femoris | 1 month / 6 months / 1 year |
| Limb salvage | 1 month / 6 months / 1 year |
| Freedom from any reinterventions | 1 month / 6 months / 1 year |
Countries
Italy
Contacts
Primary ContactNicola Troisi, Prof
Outcome results
None listed