SUPERSUBII: SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- Freedom from Restenosis [12 months]
Freedom from restenosis (diameter stenosis > 50%, determined by peak systolic velocity ratio (PSVR) >2.4 by duplex ultrasonography)
- 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 [12 Months]
Incidence of the composite of all Major Adverse Events
- Composite of All Major Adverse Events [24 Months]
Incidence of the composite of all Major Adverse Events
- Incidence of Major Adverse Events [12 months]
Incidence of Major Adverse Events
- Incidence of Major Adverse Events [24 months]
Incidence of Major Adverse Events
- Stent integrity assessment [12 months]
Stent integrity assessment will be evaluated with two oblique opposite projection X-ray images
- 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 [6 months]
Quality of Life improvement as assessed by EQ5D Questionnaire
- Quality of Life improvement [6 months]
Quality of Life improvement as assessed by SF12 Questionnaire
- Quality of Life [12 months]
Quality of Life improvement as assessed by EQ5D Questionnaire
- Quality of Life improvement [12 months]
Quality of Life improvement as assessed by SF12 Questionnaire
- Quality of Life [24 months]
Quality of Life improvement as assessed by EQ5D Questionnaire
- Quality of Life improvement [24 months]
Quality of Life improvement as assessed by SF12 Questionnaire
- Amputation Rates [1 month]
Major and Minor amputations
- Amputation Rates [6 months]
Major and Minor amputations
- Amputation Rates [12 months]
Major and Minor amputations
- Amputation Rates [24 months]
Major and Minor amputations
Other Outcome Measures
- 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.
- Cost-efficiency analysis [24 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.
- 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
- ABI index or transcutaneous oxymetry (TcPO2) improvement [6 and 12 months vs baseline]
Improve in the ABI index or transcutaneous oxymetry (TcPO2)
Eligibility Criteria
Criteria
Inclusion Criteria:
General Inclusion Criteria:
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Patients with CLI and TASC C-D Fem-Pop CTO's
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Age ≥18 years
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Patient has signed an approved consent form
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Patients without previous stenting of the Fem-Pop segment
Angiographic Inclusion Criteria:
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Patent and hemodynamically normal iliac and common femoral arteries.
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At least one patent and healthy tibial vessel runoff to the foot.
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Patient has documented TASC C or D Fem-Pop CTO's prior to the study procedure
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Rutherford Category 4, 5 or 6
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Subintimal crossing of the occluded Fem-Pop vessels
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Supera Stenting From healthy to healthy arterial segment.
Exclusion Criteria:
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Patient unwilling or unlikely to comply with Follow-Up schedule
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Endoluminal crossing of the CTO
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Inability to stent from "healthy to healthy" arterial segments.
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Inability to re-enter within the pre-specified Ideal Landing Zone (IDL)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Metro Health Hospital | Wyoming | Michigan | United States | 49519 |
| 2 | Instituto Medico CENICLAR, Unidad Sanatorio de la Mujer | Rosario | Santa Fe | Argentina | S2000 |
| 3 | Ospedale di Avezzano | Avezzano | AQ | Italy | 67051 |
| 4 | Clinica San Michele | Maddaloni | CE | Italy | 81024 |
| 5 | A.O.U. Policlinico Vittorio Emanuele | Catania | CT | Italy | 95123 |
| 6 | A.O. Cardinale Panico | Tricase | LE | Italy | 73039 |
| 7 | Casa di Cura Abano Terme | Abano Terme | Padova | Italy | 35031 |
| 8 | A.O.U. Santa Maria della Misericordia | Perugia | PG | Italy | 06129 |
| 9 | Policlinico Tor Vergata | Roma | RM | Italy | 00133 |
| 10 | A.O. San Giovanni Addolorata | Roma | RM | Italy | 00184 |
| 11 | A.O.U. di Sassari | Sassari | SS | Italy | 07100 |
| 12 | Ospedale San Antonio Abate | Erice | TP | Italy | 91016 |
| 13 | Azienda Ospedaliera Santa Maria di Terni | Terni | TR | Italy | 05100 |
| 14 | AORN Antonio Cardarelli | Napoli | Italy | 80131 | |
| 15 | London North West HealthCare NHS Trust | London | England | United Kingdom | HA1 3UJ |
Sponsors and Collaborators
- EndoCore Lab s.r.l.
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- EndoCore01