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

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.

Study Overview

• Status: Completed
• Conditions: PAD
• Intervention / Treatment: Device: Stent Peripheral System

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 Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

Study Locations

• Argentina
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000
      • Instituto Medico CENICLAR, Unidad Sanatorio de la Mujer
• Italy
  • Napoli, Italy, 80131
    • AORN Antonio Cardarelli
  • AQ
    • Avezzano, AQ, Italy, 67051
      • Ospedale di Avezzano
  • CE
    • Maddaloni, CE, Italy, 81024
      • Clinica San Michele
  • CT
    • Catania, CT, Italy, 95123
      • A.O.U. Policlinico Vittorio Emanuele
  • LE
    • Tricase, LE, Italy, 73039
      • A.O. Cardinale Panico
  • PG
    • Perugia, PG, Italy, 06129
      • A.O.U. Santa Maria della Misericordia
  • Padova
    • Abano Terme, Padova, Italy, 35031
      • Casa di Cura Abano Terme
  • RM
    • Roma, RM, Italy, 00133
      • Policlinico Tor Vergata
    • Roma, RM, Italy, 00184
      • A.O. San Giovanni Addolorata
  • SS
    • Sassari, SS, Italy, 07100
      • A.O.U. di Sassari
  • TP
    • Erice, TP, Italy, 91016
      • Ospedale San Antonio Abate
  • TR
    • Terni, TR, Italy, 05100
      • Azienda Ospedaliera Santa Maria di Terni
• United Kingdom
  • England
    • London, England, United Kingdom, HA1 3UJ
      • London North West Healthcare NHS Trust
• United States
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • Metro Health Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients affected by lower extremities artery disease and referred for the endovascular treatment of de novo or re-stenotic lesions (no in stent restenosis) in the femoro-popliteal arteries.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from Restenosis	Freedom from restenosis (diameter stenosis > 50%, determined by peak systolic velocity ratio (PSVR) >2.4 by duplex ultrasonography)	12 months
Freedom from Restenosis	Freedom from restenosis (diameter stenosis > 50%, determined by peak systolic velocity ratio (PSVR) >2.4 by duplex ultrasonography)	24 months
Composite of All Major Adverse Events	Incidence of the composite of all Major Adverse Events	12 Months
Composite of All Major Adverse Events	Incidence of the composite of all Major Adverse Events	24 Months
Incidence of Major Adverse Events	Incidence of Major Adverse Events	12 months
Incidence of Major Adverse Events	Incidence of Major Adverse Events	24 months
Stent integrity assessment	Stent integrity assessment will be evaluated with two oblique opposite projection X-ray images	12 months
Stent integrity assessment	Stent integrity assessment will be evaluated with two oblique opposite projection X-ray images	24 months
Primary Sustained Clinical Improvement	Clinical Improvement as assessed by Rutherford Class changes	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]	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]	6 months
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	12 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]	12 months
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	24 months
Quality of Life improvement	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]	24 months
Amputation Rates	Major and Minor amputations	1 month
Amputation Rates	Major and Minor amputations	6 months
Amputation Rates	Major and Minor amputations	12 months
Amputation Rates	Major and Minor amputations	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-efficiency analysis	Cost-efficiency analysis based on the comparison of the yearly procedural related costs and hospital stay(s) between patients treated with the SUPERSUB strategy, vs a propensity-matched historical cohort of patients with the same type of lesions (TASC C-D), treated by PTA alone, after subintimal crossing.	12 months
Cost-efficiency analysis	Cost-efficiency analysis based on the comparison of the yearly procedural related costs and hospital stay(s) between patients treated with the SUPERSUB strategy, vs a propensity-matched historical cohort of patients with the same type of lesions (TASC C-D), treated by PTA alone, after subintimal crossing.	24 months
Technical success	Technical success defined as achievement of a final in-lesion residual diameter stenosis of ≤30% as determined by the angiographic core lab	1 month
Clinical success	Clinical success defined as technical success without the occurrence of major adverse events	1 month
Procedural success	Procedural success defined as lesion success without the occurrence of major adverse events	1 month
ABI index or transcutaneous oxymetry (TcPO2) improvement	Improve in the ABI index or transcutaneous oxymetry (TcPO2)	6 and 12 months vs baseline

Collaborators and Investigators

• Sponsor: EndoCore Lab s.r.l.
• Collaborators: Fondazione Italiana Vascolare
• Investigators: Study Director: Maria Salomone, MD, EndoCore Lab; Study Chair: Mariano L Palena, MD, Casa di Cura Abano Terme; Study Chair: Larry J Diaz, MD,PhD, Metro Health Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Actual): March 28, 2022
• Study Completion (Actual): March 28, 2022

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 2, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: EndoCore01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No