PAD
Conditions
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.
Interventions
DEVICEStent Peripheral System
Peripheral PTA with Supera Stent implantation
Sponsors
Fondazione Italiana Vascolare
EndoCore Lab s.r.l.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Amputation Rates | 1 month | Major and Minor amputations |
| Stent integrity assessment | 12 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) | 6 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 \[1 - Best score, Value 5 - Worse Score\] |
| Quality of Life improvement (SF12 Questionnaire) | 6 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 \[ 1-Excellent, 2- Very Good, 3-Good, 4-Acceptable, 5-Poor\] |
| Freedom from Restenosis | 12 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 | 12 Months | Incidence of the composite of all Major Adverse Events |
| Incidence of Major Adverse Events | 12 months | Incidence of Major Adverse Events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Technical success | 1 month | Technical success defined as achievement of a final in-lesion residual diameter stenosis of ≤30% as determined by the angiographic core lab |
| Clinical success | 1 month | Clinical success defined as technical success without the occurrence of major adverse events |
| Procedural success | 1 month | Procedural success defined as lesion success without the occurrence of major adverse events |
| Cost-efficiency analysis | 12 months | 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. |
| ABI index or transcutaneous oxymetry (TcPO2) improvement | 6 and 12 months vs baseline | Improve in the ABI index or transcutaneous oxymetry (TcPO2) |
Countries
Argentina, Italy, United Kingdom, United States
Outcome results
None listed