Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents (NCT03020290) | Clinical Trial Compass
CompletedNot Applicable
Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents
France335 participantsStarted 2016-12
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used something called the Rutherford classification to measure improvement — can you explain what that scale means for my condition and what 'improving at least one category' would actually look like for me in terms of symptoms or daily life?
2The trial involved stenting a long segment of the superficial femoral artery — given the length of my affected artery, is this kind of extended stenting approach something my anatomy would even be suitable for, and what are the risks specific to longer stent placements?
3Since this trial has already completed, have the results been published, and if so, what did they show about how well the SuperA interwoven nitinol stent held up over time in patients with my type of blockage?
4Before considering a stenting procedure like the one studied in this trial, are there standard non-surgical treatments — like supervised exercise therapy or medications — that I should try first, and how would you decide when it's time to move on to a stent?
5This trial was listed as 'Phase NA,' which I understand often applies to device studies rather than drug trials — can you explain how that affects what we know about the safety and long-term durability of this particular stent compared to other options already approved for my condition?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patient with improvement of at least one category of Rutherford classification