Peripheral Arterial Disease Clinical Trial
— FESTIVALOfficial title:
Endovascular Treatment of Primary Common FEmoral Artery atheroSclerotic Disease wiTh IntraVAscular Litothripsy: the FESTIVAL Registry
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 |
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
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 |
Country | Name | City | State |
---|---|---|---|
Italy | University of Pisa | Pisa |
Lead Sponsor | Collaborator |
---|---|
University of Pisa |
Italy,
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
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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