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

EndoCore Lab s.r.l.92 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

PAD

Interventions

Stent Peripheral SystemDEVICE

Peripheral PTA with Supera Stent implantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (15)

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

Outcomes

Primary Outcomes

Primary Patency Rate

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)

Time frame: 24 months

Secondary Outcomes

Freedom from Restenosis

Freedom from restenosis (diameter stenosis \> 50%, determined by peak systolic velocity ratio (PSVR) \>2.4 by duplex ultrasonography)

Time frame: 12 months

Freedom from Restenosis

Freedom from restenosis (diameter stenosis \> 50%, determined by peak systolic velocity ratio (PSVR) \>2.4 by duplex ultrasonography)

Time frame: 24 months

Composite of All Major Adverse Events

Incidence of the composite of all Major Adverse Events

Time frame: 12 Months

Composite of All Major Adverse Events

Incidence of the composite of all Major Adverse Events

Time frame: 24 Months

Incidence of Major Adverse Events

Time frame: 12 months

Incidence of Major Adverse Events

Time frame: 24 months

Stent integrity assessment

Stent integrity assessment will be evaluated with two oblique opposite projection X-ray images

Data from ClinicalTrials.gov

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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

...and 5 more locations

Time frame: 12 months

Stent integrity assessment

Stent integrity assessment will be evaluated with two oblique opposite projection X-ray images

Time frame: 24 months

Primary Sustained Clinical Improvement

Clinical Improvement as assessed by Rutherford Class changes

Time frame: 6,12 and 24 months vs baseline

Quality of Life (EQ-5D-5L Questionnaire)

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 \[1 - Best score, Value 5 - Worse Score\]

Time frame: 6 months

Quality of Life improvement (SF12 Questionnaire)

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 \[ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor\]

Time frame: 6 months

Quality of Life (EQ-5D-5L Questionnaire)

Time frame: 12 months

Quality of Life improvement (SF12 Questionnaire)

Time frame: 12 months

Quality of Life (EQ-5D-5L Questionnaire)

Time frame: 24 months

Quality of Life improvement

Time frame: 24 months

Amputation Rates

Major and Minor amputations

Time frame: 1 month

Amputation Rates

Major and Minor amputations

Time frame: 6 months

Amputation Rates

Major and Minor amputations

Time frame: 12 months

Amputation Rates

Major and Minor amputations

Time frame: 24 months