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

PAD Clinical Trial

— SUPERSUBII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452293
• Other study ID #: EndoCore01
• Status: Completed
• Start date: March 7, 2018
• Est. completion date: March 28, 2022

Study information

• Verified date: October 2022
• Source: EndoCore Lab s.r.l.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: March 28, 2022
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• PAD

Intervention

Device:
• Stent Peripheral System
Peripheral PTA with Supera Stent implantation

Locations

Country	Name	City	State
Argentina	Instituto Medico CENICLAR, Unidad Sanatorio de la Mujer	Rosario	Santa Fe
Italy	Casa di Cura Abano Terme	Abano Terme	Padova
Italy	Ospedale di Avezzano	Avezzano	AQ
Italy	A.O.U. Policlinico Vittorio Emanuele	Catania	CT
Italy	Ospedale San Antonio Abate	Erice	TP
Italy	Clinica San Michele	Maddaloni	CE
Italy	AORN Antonio Cardarelli	Napoli
Italy	A.O.U. Santa Maria della Misericordia	Perugia	PG
Italy	A.O. San Giovanni Addolorata	Roma	RM
Italy	Policlinico Tor Vergata	Roma	RM
Italy	A.O.U. di Sassari	Sassari	SS
Italy	Azienda Ospedaliera Santa Maria di Terni	Terni	TR
Italy	A.O. Cardinale Panico	Tricase	LE
United Kingdom	London North West HealthCare NHS Trust	London	England
United States	Metro Health Hospital	Wyoming	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
EndoCore Lab s.r.l.	Fondazione Italiana Vascolare

Countries where clinical trial is conducted

United States,  Argentina,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Clinical success	Clinical success defined as technical success without the occurrence of major adverse events	1 month
Other	Procedural success	Procedural success defined as lesion success without the occurrence of major adverse events	1 month
Other	ABI index or transcutaneous oxymetry (TcPO2) improvement	Improve in the ABI index or transcutaneous oxymetry (TcPO2)	6 and 12 months vs baseline
Primary	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	Freedom from Restenosis	Freedom from restenosis (diameter stenosis > 50%, determined by peak systolic velocity ratio (PSVR) >2.4 by duplex ultrasonography)	12 months
Secondary	Freedom from Restenosis	Freedom from restenosis (diameter stenosis > 50%, determined by peak systolic velocity ratio (PSVR) >2.4 by duplex ultrasonography)	24 months
Secondary	Composite of All Major Adverse Events	Incidence of the composite of all Major Adverse Events	12 Months
Secondary	Composite of All Major Adverse Events	Incidence of the composite of all Major Adverse Events	24 Months
Secondary	Incidence of Major Adverse Events	Incidence of Major Adverse Events	12 months
Secondary	Incidence of Major Adverse Events	Incidence of Major Adverse Events	24 months
Secondary	Stent integrity assessment	Stent integrity assessment will be evaluated with two oblique opposite projection X-ray images	12 months
Secondary	Stent integrity assessment	Stent integrity assessment will be evaluated with two oblique opposite projection X-ray images	24 months
Secondary	Primary Sustained Clinical Improvement	Clinical Improvement as assessed by Rutherford Class changes	6,12 and 24 months vs baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Amputation Rates	Major and Minor amputations	1 month
Secondary	Amputation Rates	Major and Minor amputations	6 months
Secondary	Amputation Rates	Major and Minor amputations	12 months
Secondary	Amputation Rates	Major and Minor amputations	24 months