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NCT05821829 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

— FESTIVAL  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05821829
Other study ID # FESTIVAL
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date May 1, 2025

Study information
Verified date May 2023
Source University of Pisa
Contact Nicola Troisi, Prof
Phone 00393280205530
Email nicola.troisi@unipi.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date May 1, 2025
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Intravascular litothripsy (IVL)
endovascular treatment of primary common femoral artery atherosclerotic disease with intravascular litothripsy

Locations
Country Name City State
Italy University of Pisa Pisa

Sponsors (1)
Lead Sponsor Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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 Revas — View 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 Random — View 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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Primary patency patency of the treated vessel in the absence of a restenosis >30% 1 month / 6 months / 1 year
Primary Primary assisted patency patency of the treated vessel after one or more endovascular reinterventions 1 month / 6 months / 1 year
Primary Secondary patency patency of the treated vessel after occlusione and treatment by surgical or endovascular means 1 month / 6 months / 1 year
Primary 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 Freedom from any reinterventions 1 month / 6 months / 1 year
Secondary Patency of profunda femoris 1 month / 6 months / 1 year
Secondary Limb salvage 1 month / 6 months / 1 year
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