Clinical trial NCT03452293: SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients
Official title: SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PAD
Lead sponsor: EndoCore Lab s.r.l.
Sponsor class: OTHER
Collaborators: name: Fondazione Italiana Vascolare
First posted: 2018-03-02
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Primary Patency Rate
timeFrame: 24 months
Secondary outcomes:
measure: Freedom from Restenosis
timeFrame: 12 months
measure: Freedom from Restenosis
timeFrame: 24 months
measure: Composite of All Major Adverse Events
timeFrame: 12 Months
measure: Composite of All Major Adverse Events
timeFrame: 24 Months
measure: Incidence of Major Adverse Events
timeFrame: 12 months
measure: Incidence of Major Adverse Events
timeFrame: 24 months
measure: Stent integrity assessment
timeFrame: 12 months
measure: Stent integrity assessment
timeFrame: 24 months
measure: Primary Sustained Clinical Improvement
timeFrame: 6,12 and 24 months vs baseline
measure: Quality of Life (EQ-5D-5L Questionnaire)
timeFrame: 6 months
measure: Quality of Life improvement (SF12 Questionnaire)
timeFrame: 6 months
measure: Quality of Life (EQ-5D-5L Questionnaire)
timeFrame: 12 months
measure: Quality of Life improvement (SF12 Questionnaire)
timeFrame: 12 months
measure: Quality of Life (EQ-5D-5L Questionnaire)
timeFrame: 24 months
measure: Quality of Life improvement
timeFrame: 24 months
measure: Amputation Rates
timeFrame: 1 month
measure: Amputation Rates
timeFrame: 6 months
measure: Amputation Rates
timeFrame: 12 months
measure: Amputation Rates
timeFrame: 24 months
Other outcomes:
measure: Cost-efficiency analysis
timeFrame: 12 months
measure: Cost-efficiency analysis
timeFrame: 24 months
measure: Technical success
timeFrame: 1 month
measure: Clinical success
timeFrame: 1 month
measure: Procedural success
timeFrame: 1 month
measure: ABI index or transcutaneous oxymetry (TcPO2) improvement
timeFrame: 6 and 12 months vs baseline
Locations:
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
city: Rosario
country: Argentina
facility: Instituto Medico CENICLAR, Unidad Sanatorio de la Mujer
state: Santa Fe
city: Avezzano
country: Italy
facility: Ospedale di Avezzano
state: AQ
city: Maddaloni
country: Italy
facility: Clinica San Michele
state: CE
city: Catania
country: Italy
facility: A.O.U. Policlinico Vittorio Emanuele
state: CT
city: Tricase
country: Italy
facility: A.O. Cardinale Panico
state: LE
city: Abano Terme
country: Italy
facility: Casa di Cura Abano Terme
state: Padova
city: Perugia
country: Italy
facility: A.O.U. Santa Maria della Misericordia
state: PG
city: Roma
country: Italy
facility: Policlinico Tor Vergata
state: RM
city: Roma
country: Italy
facility: A.O. San Giovanni Addolorata
state: RM
city: Sassari
country: Italy
facility: A.O.U. di Sassari
state: SS
city: Erice
country: Italy
facility: Ospedale San Antonio Abate
state: TP
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria di Terni
state: TR
city: Napoli
country: Italy
facility: AORN Antonio Cardarelli
city: London
country: United Kingdom
facility: London North West HealthCare NHS Trust
state: England
Study officials:
affiliation: EndoCore Lab
name: Maria Salomone, MD
role: STUDY_DIRECTOR
affiliation: Casa di Cura Abano Terme
name: Mariano L Palena, MD
role: STUDY_CHAIR
affiliation: Metro Health Hospital
name: Larry J Diaz, MD,PhD
role: STUDY_CHAIR
References: