SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients

Completed

Conditions studied: PAD

In brief

The study will evaluate the safety and efficacy of subintimal Supera stenting in complex de novo or re-occlusive CTO (TASC C-D) lesions in patients with CLI. This study will be performed based on a rigorous sample size calculation, which will allow us to have the statistical power to validate our conclusions and therefore establish the generalizability of this strategy.

Key facts

Study ID

NCT03452293

Run by

EndoCore Lab s.r.l.

People needed

92

Starts

2018-03-07

Expected to finish

2022-03-28

Last updated by the study team

2022-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• General Inclusion Criteria:
• Patients with CLI and TASC C-D Fem-Pop CTO's
• Age ≥18 years
• Patient has signed an approved consent form
• Patients without previous stenting of the Fem-Pop segment
• Angiographic Inclusion Criteria:
• Patent and hemodynamically normal iliac and common femoral arteries.
• At least one patent and healthy tibial vessel runoff to the foot.
• Patient has documented TASC C or D Fem-Pop CTO's prior to the study procedure
• Rutherford Category 4, 5 or 6
• Subintimal crossing of the occluded Fem-Pop vessels
• Supera Stenting From healthy to healthy arterial segment.

You may not qualify if…

• Patient unwilling or unlikely to comply with Follow-Up schedule
• Endoluminal crossing of the CTO
• Inability to stent from "healthy to healthy" arterial segments.
• Inability to re-enter within the pre-specified Ideal Landing Zone (IDL)

Where it is running

• Metro Health Hospital — Wyoming, Michigan, United States
• Instituto Medico CENICLAR, Unidad Sanatorio de la Mujer — Rosario, Santa Fe Province, Argentina
• Ospedale di Avezzano — Avezzano, AQ, Italy
• Clinica San Michele — Maddaloni, CE, Italy
• A.O.U. Policlinico Vittorio Emanuele — Catania, CT, Italy
• A.O. Cardinale Panico — Tricase, LE, Italy
• Casa di Cura Abano Terme — Abano Terme, Padova, Italy
• A.O.U. Santa Maria della Misericordia — Perugia, PG, Italy
• Policlinico Tor Vergata — Roma, RM, Italy
• A.O. San Giovanni Addolorata — Roma, RM, Italy
• A.O.U. di Sassari — Sassari, SS, Italy
• Ospedale San Antonio Abate — Erice, TP, Italy
• Azienda Ospedaliera Santa Maria di Terni — Terni, TR, Italy
• AORN Antonio Cardarelli — Naples, Italy
• London North West HealthCare NHS Trust — London, England, United Kingdom

Full record on ClinicalTrials.gov

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