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

Study Overview
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Brief Summary
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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

Official Title
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Endovascular Treatment of Primary Common FEmoral Artery atheroSclerotic Disease wiTh IntraVAscular Litothripsy: the FESTIVAL Registry

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

Intervention / Treatment
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* Device: Intravascular litothripsy (IVL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with peripheral arterial disease (Rutherford class 3-6) Presence of a steno-obstructive lesion of the common femoral artery (Azema classification 1-3) Possible endovascular treatment of both the iliac axis and/or femoro-distal vessels Possible post-dilatation with plain or drug-coated balloon angioplasty Exclusion Criteria: Concomitant open surgery (ilio-femoral or femoro-distal bypass) Presence of a steno-obstructive lesion of the common femoral artery in previous open surgery (Azema classification 4) Presence of a steno-obstructive lesion of the common femoral artery after a previous endovascular procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Intravascular litothripsy (IVL)|endovascular treatment of primary common femoral artery atherosclerotic disease with intravascular litothripsy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Intraprocedural | 
| Clinical success | absence of intraprocedural complications including distal embolization and improvement of at least 1 Rutherford class assessed 1 month after the procedure | Intraprocedural / 1 month | 
| Primary patency | patency of the treated vessel in the absence of a restenosis >30% | 1 month / 6 months / 1 year | 
| Primary assisted patency | patency of the treated vessel after one or more endovascular reinterventions | 1 month / 6 months / 1 year | 
| Secondary patency | patency of the treated vessel after occlusione and treatment by surgical or endovascular means | 1 month / 6 months / 1 year | 
| Clinically driven freedom from target lesion restenosis (cdTLR) | restenosis resulting in vessel occlusion or stenosis with maximum PSV > 2.5 m/sec | 1 month / 6 months / 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from any reinterventions |  | 1 month / 6 months / 1 year | 
| Patency of profunda femoris |  | 1 month / 6 months / 1 year | 
| Limb salvage |  | 1 month / 6 months / 1 year |