Status:
COMPLETED
SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients
Lead Sponsor:
EndoCore Lab s.r.l.
Collaborating Sponsors:
Fondazione Italiana Vascolare
Conditions:
PAD
Eligibility:
All Genders
18+ years
Brief Summary
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 ri...
Detailed 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 addition...
Eligibility Criteria
Inclusion
- General
- 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
- 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
- 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)
Key Trial Info
Start Date :
March 7 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 28 2022
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT03452293
Start Date
March 7 2018
End Date
March 28 2022
Last Update
November 2 2022
Active Locations (15)
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1
Metro Health Hospital
Wyoming, Michigan, United States, 49519
2
Instituto Medico CENICLAR, Unidad Sanatorio de la Mujer
Rosario, Santa Fe Province, Argentina, S2000
3
Ospedale di Avezzano
Avezzano, AQ, Italy, 67051
4
Clinica San Michele
Maddaloni, CE, Italy, 81024