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OpenTrials
Completed

NCT Number: NCT03452293

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

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.

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Key information

Conditions

PAD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Medico CENICLAR, Unidad Sanatorio de la Mujer, Rosario, Santa Fe Province, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Stent Peripheral System

Device

Peripheral PTA with Supera Stent implantation

Primary outcomes

  1. Primary Patency Rate

    Time frame: 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 outcomes

  1. Freedom from Restenosis

    Time frame: 12 months

    Freedom from restenosis (diameter stenosis > 50%, determined by peak systolic velocity ratio (PSVR) >2.4 by duplex ultrasonography)

  2. Freedom from Restenosis

    Time frame: 24 months

    Freedom from restenosis (diameter stenosis > 50%, determined by peak systolic velocity ratio (PSVR) >2.4 by duplex ultrasonography)

  3. Composite of All Major Adverse Events

    Time frame: 12 Months

    Incidence of the composite of all Major Adverse Events

  4. Composite of All Major Adverse Events

    Time frame: 24 Months

    Incidence of the composite of all Major Adverse Events

  5. Incidence of Major Adverse Events

    Time frame: 12 months

    Incidence of Major Adverse Events

  6. Incidence of Major Adverse Events

    Time frame: 24 months

    Incidence of Major Adverse Events

  7. Stent integrity assessment

    Time frame: 12 months

    Stent integrity assessment will be evaluated with two oblique opposite projection X-ray images

  8. Stent integrity assessment

    Time frame: 24 months

    Stent integrity assessment will be evaluated with two oblique opposite projection X-ray images

  9. Primary Sustained Clinical Improvement

    Time frame: 6,12 and 24 months vs baseline

    Clinical Improvement as assessed by Rutherford Class changes

  10. Quality of Life (EQ-5D-5L Questionnaire)

    Time frame: 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]

  11. Quality of Life improvement (SF12 Questionnaire)

    Time frame: 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]

  12. Quality of Life (EQ-5D-5L Questionnaire)

    Time frame: 12 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

  13. Quality of Life improvement (SF12 Questionnaire)

    Time frame: 12 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]

  14. Quality of Life (EQ-5D-5L Questionnaire)

    Time frame: 24 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

  15. Quality of Life improvement

    Time frame: 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]

  16. Amputation Rates

    Time frame: 1 month

    Major and Minor amputations

  17. Amputation Rates

    Time frame: 6 months

    Major and Minor amputations

  18. Amputation Rates

    Time frame: 12 months

    Major and Minor amputations

  19. Amputation Rates

    Time frame: 24 months

    Major and Minor amputations

Other outcomes

  1. Cost-efficiency analysis

    Time frame: 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.

  2. Cost-efficiency analysis

    Time frame: 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.

  3. Technical success

    Time frame: 1 month

    Technical success defined as achievement of a final in-lesion residual diameter stenosis of ≤30% as determined by the angiographic core lab

  4. Clinical success

    Time frame: 1 month

    Clinical success defined as technical success without the occurrence of major adverse events

  5. Procedural success

    Time frame: 1 month

    Procedural success defined as lesion success without the occurrence of major adverse events

  6. ABI index or transcutaneous oxymetry (TcPO2) improvement

    Time frame: 6 and 12 months vs baseline

    Improve in the ABI index or transcutaneous oxymetry (TcPO2)

Sponsors and collaborators

Lead sponsor

EndoCore Lab s.r.l.

Other

Collaborators

  • Fondazione Italiana Vascolare

Registry information

Acronym: SUPERSUBII

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2018
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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