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

Recruiting

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

• Registration Number: NCT05821829
• Lead Sponsor: University of Pisa

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-07
• Study First Submitted QC: 2023-04-07
• Study First Posted: 2023-04-20
• Status Verified: 2023-05
• Study Start: 2023-05-01
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10
• Primary Completion: 2024-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical success	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	1 month / 6 months / 1 year	patency of the treated vessel after occlusione and treatment by surgical or endovascular means
Clinical success	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	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)	1 month / 6 months / 1 year	restenosis resulting in vessel occlusion or stenosis with maximum PSV \> 2.5 m/sec
Primary patency	1 month / 6 months / 1 year	patency of the treated vessel in the absence of a restenosis \>30%

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Pisa; 🇮🇹 Pisa, Italy