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

NCT05821829 | Unknown

• 1 other identifier: FESTIVAL
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• 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

Interventions

Intravascular litothripsy (IVL) DEVICE

endovascular treatment of primary common femoral artery atherosclerotic disease with intravascular litothripsy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with severely symptomatic peripheral arterial disease and concomitant atherosclerotic de novo lesions of the common femoral artery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

University of Pisa

Pisa, 50012, Italy

RECRUITING

Related 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 Revasc Med. 2022 Oct;43:80-84. doi: 10.1016/j.carrev.2022.05.003. Epub 2022 May 7.

  PMID: 35595607 RESULT

• 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.

  PMID: 34887206 RESULT

• 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.

  PMID: 34167675 RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Nicola Troisi, Prof

CONTACT

00393280205530; nicola.troisi@unipi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Vascular Surgery

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 20, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

IT (1)