Clinical trial NCT05821829: Endovascular Treatment of Primary Common FEmoral Artery atheroSclerotic Disease wiTh IntraVAscular Litothripsy
Official title: Endovascular Treatment of Primary Common FEmoral Artery atheroSclerotic Disease wiTh IntraVAscular Litothripsy: the FESTIVAL Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Arterial Disease
Common Femoral Artery Stenosis
Common Femoral Artery Occlusion
Critical Limb-Threatening Ischemia
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severely symptomatic peripheral arterial disease and concomitant atherosclerotic de novo lesions of the common femoral artery

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


Eligibility criteria: 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

Primary outcomes:
measure: Technical success
timeFrame: Intraprocedural
measure: Clinical success
timeFrame: Intraprocedural / 1 month
measure: Primary patency
timeFrame: 1 month / 6 months / 1 year
measure: Primary assisted patency
timeFrame: 1 month / 6 months / 1 year
measure: Secondary patency
timeFrame: 1 month / 6 months / 1 year
measure: Clinically driven freedom from target lesion restenosis (cdTLR)
timeFrame: 1 month / 6 months / 1 year
Secondary outcomes:
measure: Freedom from any reinterventions
timeFrame: 1 month / 6 months / 1 year
measure: Patency of profunda femoris
timeFrame: 1 month / 6 months / 1 year
measure: Limb salvage
timeFrame: 1 month / 6 months / 1 year
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University of Pisa
Study officials:
References:
citation: Baig M, Kwok M, Aldairi A, Imran HM, Khan MS, Moustafa A, Hyder ON, Saad M, Aronow HD, Soukas PA. Endovascular Intravascular Lithotripsy in the Treatment of Calcific Common Femoral Artery Disease: A Case Series With an 18-Month Follow-Up. Cardiovasc Revasc Med. 2022 Oct;43:80-84. doi: 10.1016/j.carrev.2022.05.003. Epub 2022 May 7.
citation: Wong CP, Chan LP, Au DM, Chan HWC, Chan YC. Efficacy and Safety of Intravascular Lithotripsy in Lower Extremity Peripheral Artery Disease: A Systematic Review and Meta-Analysis. Eur J Vasc Endovasc Surg. 2022 Mar;63(3):446-456. doi: 10.1016/j.ejvs.2021.10.035. Epub 2021 Dec 6.
citation: Tepe G, Brodmann M, Werner M, Bachinsky W, Holden A, Zeller T, Mangalmurti S, Nolte-Ernsting C, Bertolet B, Scheinert D, Gray WA; Disrupt PAD III Investigators. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361. doi: 10.1016/j.jcin.2021.04.010.