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Completed

NCT Number: NCT03020290

Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents

Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal lesions. This technique tends to extend to lesions for which the gold standard remains until now the open surgery treatment (lesions TASC C and D).

The primary objective of the study was to evaluate the clinical efficacy at 12 months of the SuperA stent (Abbott) in the treatment of long de novo atherosclerotic lesions TASC C and D in patients with symptomatic peripheral arterial disease. The secondary objectives are to evaluate the clinical effectiveness of the SuperA stent at 24 months, according to clinical, morphological and haemodynamic criteria, the possible influence of calcifications and the quality of life of patients.

The SuperA stent treatment is not specifically provided for by the Protocol but is carried out within the framework of the care. This study is an observationnal study.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHD Vendée, La Roche-sur-Yon, France

Loading trial locations.

About this study

Patient will be recruiting during 1 year. Patient will be followed in the study during 2 years. Pre-operative exams are collected. Patients are asked to give their oral authorization to participate in the study by their surgeon.

Patient can be included up to the next day of the intervention.

Endovascular treatment of femoropopliteal lesion with SuperA stents during medical care:

Intervention will be achieved in operative room, under local anesthesia and sedation or general anesthesia. An angio-CT or an arteriography is necessary to attest the presence for TASC C or D lesion involving the superficial femoral and/or popliteal arteries.

The long femoropopliteal lesion must be pre-dilated during 3 minutes with a balloon of 1mm diameter more than the stent to be implanted.

A control arteriography will be done before the implantation of the stent and at the end of the intervention to assess the success of the procedure.

If needed, endovascular treatment could be realized on the inflow or outflow in the same time.

Patient follow-up :

Patient follow-up is performed at 1, 6, 12 and 24 months. Follow-up will systematically include a clinical evaluation and a duplex scan with the ankle brachial index (ABI).

The x-rays and the quality of life questionnaire will be done at 1, 12 and 24 months.

All clinical surveillance events, complications and re-hospitalizations will be collected.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years,
  • Symptomatic PAD, Rutherford 2 to 6
  • Atherosclerotic femoropopliteal lesion TASC C or D (on CT scan or arteriography)
  • De novo femoropopliteal lesion
  • Patient informed of the study and oral authorization collected

Exclusion criteria

  • Under-age patient
  • Patient of age, but under legal guardianship or care
  • Potentially pregnant women
  • Patients do not understand the French language
  • Asymptomatic lesion
  • Acute ischemia or acute thrombosis
  • Lesion already treated
  • No-atherosclerotic disease
  • hemostasis disorder
  • severe comorbidity with life expectancy less than 2 years
  • contraindication of antiplatelet (dual antiplatelet therapy required during at least 2 month post-intervention)
  • patient participating in a clinical trial likely to interfer
  • Comorbidity or other, according investigator, that may interferer with the conduct of the study
  • lesion near to an aneurysm
  • Patient follow-up impossible
  • Patient refuse to participate

Treatment and study plan

Endovascular treatment for PAD during medical care (SuperA stent (Abbott))

Device

Long femoropopliteal stenting with SuperA devices during medical care. The endovascular treatment for PAD will be done during the usual medical treatment of patient. The intervention is not carried out within the framework of the research protocol

Other names: long femoropopliteal revascularization

Primary outcomes

  1. Number of patient with improvement of at least one category of Rutherford classification

    Time frame: 12 months

    To evaluate the sustained clinical effectiveness of the SuperA stent (Abbott) at 12-month for TASC C and D atherosclerotic femoropopliteal lesions in patients with symptomatic primary artery disease (PAD) (RUTHERFORD 2 to 6).

    Improvement of at least 1 category of Rutherford classification for claudicants.

    Healing of a trophic disorder and disappearance of resting pain for patient with critical ischemia

Secondary outcomes

  1. Number of patient with improvement of at least one category of Rutherford classification

    Time frame: 24 months

    clinical effectiveness of the SuperA stent measurement

  2. number of patient presenting a major adverse cardiovascular event

    Time frame: 24 months

    clinical effectiveness of the SuperA stent measurement

  3. number of patient presenting a major adverse limb event

    Time frame: 24 months

    clinical effectiveness of the SuperA stent measurement

  4. limb salvage rate measurement

    Time frame: 24 months

    clinical effectiveness of the SuperA stent measurement

  5. rate of Target Lesion Revascularization (TLR)

    Time frame: 24 months

    Effectiveness of the SuperA stent measurement

  6. rate of Target Extremity Revascularization (TER)

    Time frame: 24 months

    Effectiveness of the SuperA stent measurement

  7. number of patient with sustained permeability without restenosis > 30% in lack of reintervention

    Time frame: 24 months

    hemodynamic effectiveness of the SuperA stent measurement

  8. number of patient with sustained permeability without restenosis > 30% after reintervention

    Time frame: 24 months

    hemodynamic effectiveness of the SuperA stent measurement

  9. variation of the ABI (Ankle systolic pression (mmHg) / brachial systolique pression (mmHg) index) before and after surgery

    Time frame: 24 months

    hemodynamic effectiveness of the SuperA stent measurement

    (restenosis, thrombosis) and morphologic criteria (stenting length, stent fracture).

  10. restenosis measurement

    Time frame: 24 months

    hemodynamic effectiveness of the SuperA stent measurement

  11. thrombosis measurement

    Time frame: 24 months

    hemodynamic effectiveness of the SuperA stent measurement

  12. stenting length measurement

    Time frame: 24 months

    morphologic criteria of effectiveness of the SuperA stent measurement

  13. stent fracture measurement

    Time frame: 24 months

    morphologic criteria of effectiveness of the SuperA stent measurement

  14. quality of life in patients treated with the SuperA stent

    Time frame: 1 month

    EuroQol five dimensions questionnaire (EQ5D-3L)

  15. quality of life in patients treated with the SuperA stent

    Time frame: 12 months

    EQ5D-3L questionnaire

  16. quality of life in patients treated with the SuperA stent

    Time frame: 24months

    EQ5D-3L questionnaire

  17. Assessment of vessel calcification rate

    Time frame: 24months

    For predictive factors of failure

  18. Assessment of elongation rate of SuperA

    Time frame: 24months

    For predictive factors of failure

  19. Assessment of stent diameter

    Time frame: 24months

    For predictive factors of failure

  20. Number of patient presenting cardiovascular comorbidity

    Time frame: 24months

    For predictive factors of failure

  21. Number of patient presenting a renal dysfunction (creatinine clearance < 60 mL/min and/or dialysis)

    Time frame: 24months

    For predictive factors of failure

  22. Number of patient treated with anti-platelet therapy

    Time frame: 24months

    For predictive factors of failure

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Abbott

Registry information

Acronym: STELLASUPERA

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2017
Registry last updated
Sep 9, 2021

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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