Endovascular Treatment of Primary Common FEmoral Artery atheroSclerotic Disease wiTh IntraVAscular Litothripsy: the FESTIVAL Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- University of Pisa
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Technical success
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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
Investigators
Nicola Troisi
Associate Professor of Vascular Surgery
University of Pisa
Eligibility Criteria
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
Outcomes
Primary Outcomes
Technical success
Time Frame: 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
Secondary patency
Time Frame: 1 month / 6 months / 1 year
patency of the treated vessel after occlusione and treatment by surgical or endovascular means
Clinical success
Time Frame: Intraprocedural / 1 month
absence of intraprocedural complications including distal embolization and improvement of at least 1 Rutherford class assessed 1 month after the procedure
Primary assisted patency
Time Frame: 1 month / 6 months / 1 year
patency of the treated vessel after one or more endovascular reinterventions
Clinically driven freedom from target lesion restenosis (cdTLR)
Time Frame: 1 month / 6 months / 1 year
restenosis resulting in vessel occlusion or stenosis with maximum PSV \> 2.5 m/sec
Primary patency
Time Frame: 1 month / 6 months / 1 year
patency of the treated vessel in the absence of a restenosis \>30%
Secondary Outcomes
- Limb salvage(1 month / 6 months / 1 year)
- Freedom from any reinterventions(1 month / 6 months / 1 year)
- Patency of profunda femoris(1 month / 6 months / 1 year)