An observational study in PAD, sponsored by EndoCore Lab s.r.l.. Completed at 15 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-02.
Sponsored by EndoCore Lab s.r.l. · Observational
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.
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.
General Inclusion Criteria:
Angiographic Inclusion Criteria:
Exclusion Criteria:
Peripheral PTA with Supera Stent implantation
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
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
Incidence of Major Adverse Events
Time frame: 12 months
Incidence of Major Adverse Events
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
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)
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: 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 \[ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor\]
Time frame: 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
Time frame: 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 \[ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor\]
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
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.
Time frame: 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.
Time frame: 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
Time frame: 1 month
Clinical success
Clinical success defined as technical success without the occurrence of major adverse events
Time frame: 1 month
Procedural success
Procedural success defined as lesion success without the occurrence of major adverse events
Time frame: 1 month
ABI index or transcutaneous oxymetry (TcPO2) improvement
Improve in the ABI index or transcutaneous oxymetry (TcPO2)
Time frame: 6 and 12 months vs baseline
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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EndoCore Lab s.r.l.