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

EndoCore Lab

Status: Completed

Conditions: PAD

Treatments: Device: Stent Peripheral System

Study type: Observational

Funder types: Other

Identifiers

NCT03452293

EndoCore01

Details and patient eligibility

About

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.

Full description

The present study is designed as a prospective, open label, observational study.

The study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done.

Patients elected for endovascular revascularization with SuperSub strategy will be asked their written consent to the use of their personal data.

Revascularization will be performed as per standard procedure of the sites. After discharge all patients will attend clinic visits at 30 days (±14 days), 6 months (±30 days), 12 months (±30 days) and 24 months (±30 days). Angiographic follow-up will be performed only in symptomatic patients, as clinically indicated and with the aim for a new treatment.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

• 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)