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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Common Femoral Artery Stenosis
• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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