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

Completed

• Conditions: PAD

• Registration Number: NCT03452293
• Lead Sponsor: EndoCore Lab s.r.l.

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 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.

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 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.

Study Timeline

• Study First Submitted: 2018-02-14
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-02
• Study Start: 2018-03-07
• Primary Completion: 2022-03-28
• Study Completion: 2022-03-28
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Patency Rate	24 months	Primary Patency is defined as freedom from clinically driven TLR (CD-TLR) defined as repeat percutaneous intervention or surgical bypass graft to treat an angiographic significant restenosis (\>50%) at the level of the treated lesion ±10 mm (proximally and/or distally)

Secondary Outcome Measures

Name	Time	Method
Stent integrity assessment	24 months	Stent integrity assessment will be evaluated with two oblique opposite projection X-ray images
Primary Sustained Clinical Improvement	6,12 and 24 months vs baseline	Clinical Improvement as assessed by Rutherford Class changes
Quality of Life (EQ-5D-5L Questionnaire)	24 months	Quality of Life improvement as assessed by EQ-5D-5L Questionnaire Parameters \[Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression\] Values \[(1) No Problems, (2) Slight Problems, (3) Moderate Problems, (4) Severe Problems, (5) Unable to\] Value 1 - Best score, Value 5 - Worse Score
Incidence of Major Adverse Events	24 months	Incidence of Major Adverse Events
Quality of Life improvement (SF12 Questionnaire)	12 months	Quality of Life improvement as assessed by SF12 Questionnaire Parameters \[Overall Health, Physical health, Role and Physical health, Role and Mental health, Mental health\] Values for Overall Health \[ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor\] Values for Role and Physical health \[ 1-Very limiting, 2-Partially limiting, 3-Not limiting\] Values for Physical health \[ 1-yes, 2-no\], \[1- best score\] , \[2-worse score\] Values for Role and Mental health \[ 1-yes, 2-no\], \[1- best score\] , \[2-worse score\] Values for Mental Health \[ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor\]
Quality of Life improvement	24 months	Quality of Life improvement as assessed by SF12 Questionnaire Parameters \[Overall Health, Physical health, Role and Physical health, Role and Mental health, Mental health\] Values for Overall Health \[ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor\] Values for Role and Physical health \[ 1-Very limiting, 2-Partially limiting, 3-Not limiting\] Values for Physical health \[ 1-yes, 2-no\], \[1- best score\] , \[2-worse score\] Values for Role and Mental health \[ 1-yes, 2-no\], \[1- best score\] , \[2-worse score\] Values for Mental Health \[ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor\]
Amputation Rates	24 months	Major and Minor amputations
Freedom from Restenosis	24 months	Freedom from restenosis (diameter stenosis \> 50%, determined by peak systolic velocity ratio (PSVR) \>2.4 by duplex ultrasonography)
Composite of All Major Adverse Events	24 Months	Incidence of the composite of all Major Adverse Events

Trial Locations

Locations (15)

Instituto Medico CENICLAR, Unidad Sanatorio de la Mujer; 🇦🇷 Rosario, Santa Fe, Argentina

Metro Health Hospital; 🇺🇸 Wyoming, Michigan, United States

Clinica San Michele; 🇮🇹 Maddaloni, CE, Italy

Ospedale di Avezzano; 🇮🇹 Avezzano, AQ, 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

Ospedale San Antonio Abate; 🇮🇹 Erice, TP, Italy

A.O.U. di Sassari; 🇮🇹 Sassari, SS, Italy

Azienda Ospedaliera Santa Maria di Terni; 🇮🇹 Terni, TR, Italy

AORN Antonio Cardarelli; 🇮🇹 Napoli, Italy

London North West HealthCare NHS Trust; 🇬🇧 London, England, United Kingdom