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

• Sponsor: University of Pisa (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05821829
• Collaborator: (none)
• Enrollment: 150
• Anticipated Duration (Months): 24

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease; Common Femoral Artery Stenosis; Common Femoral Artery Occlusion; Critical Limb-Threatening Ischemia	Device: Intravascular litothripsy (IVL)

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Endovascular Treatment of Primary Common FEmoral Artery atheroSclerotic Disease wiTh IntraVAscular Litothripsy: the FESTIVAL Registry
• Anticipated Study Start Date: Apr 15, 2023
• Anticipated Primary Completion Date: Apr 15, 2024
• Anticipated Study Completion Date: Apr 15, 2025

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. Primary patency [1 month / 6 months / 1 year]

   patency of the treated vessel in the absence of a restenosis >30%

4. Primary assisted patency [1 month / 6 months / 1 year]

   patency of the treated vessel after one or more endovascular reinterventions

5. Secondary patency [1 month / 6 months / 1 year]

   patency of the treated vessel after occlusione and treatment by surgical or endovascular means

6. 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

Secondary Outcome Measures

1. Freedom from any reinterventions [1 month / 6 months / 1 year]

2. Patency of profunda femoris [1 month / 6 months / 1 year]

3. Limb salvage [1 month / 6 months / 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Pisa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nicola Troisi, Associate Professor of Vascular Surgery, University of Pisa
• ClinicalTrials.gov Identifier: NCT05821829
• Other Study ID Numbers: FESTIVAL
• First Posted: Apr 20, 2023
• Last Update Posted: Apr 20, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Ischemia

Study Results

No Results Posted as of Apr 20, 2023