UnknownNot Applicable

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

Italy150 participantsStarted 2023-05-01

Plain-language 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

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Technical success

Timeframe: Intraprocedural

Clinical success

Timeframe: Intraprocedural / 1 month

Primary patency

Timeframe: 1 month / 6 months / 1 year

Primary assisted patency

Timeframe: 1 month / 6 months / 1 year

Secondary patency

Timeframe: 1 month / 6 months / 1 year

Clinically driven freedom from target lesion restenosis (cdTLR)

Timeframe: 1 month / 6 months / 1 year

Trial details

NCT IDNCT05821829

SponsorUniversity of Pisa

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-05-01

Contact for this trial

Nicola Troisi, Prof

00393280205530 nicola.troisi@unipi.it

View on ClinicalTrials.gov More Peripheral Arterial Disease trials