Supera Vasculomimetic Stent: Femoral-popliteal revascularization with Supera Stent
Study summary
The SupPORT Registry aims at collecting real-world from Portuguese centers performing femoral-popliteal revascularization with Supera (r) implants. This is a prospective non-randomized non-controlled consecutive registry.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Evidence of symptomatic obstructive peripheral arterial disease.
* All-comer patients undergoing endovascular lower-limb revascularization with Supera® stent implantation in the superficial femoral (SFA) or popliteal arteries.
* Patient or legal representative understand the SupPORT registry procedures, and have voluntarily provided informed written consent regarding their participation.
* Participant is willing to remain in the SupPORT Registry for at least 1 year.
* Target lesion is a primary atherosclerotic lesion or a restenosis occurring in a non-stented of the SFA or the popliteal artery, distancing at least ≥ 1 cm from any previously implanted vascular stent.
* Target lesion causes a ≥50% arterial obstruction (visually confirmed on digital subtraction angiography).
Exclusion Criteria:
* • Any contraindication for peri-interventional or post-interventional anti-thrombotic therapy (including, but not restricted to Non-fractioned heparina, low-molecular weight heparina \[LMWH\], Clopidogrel, Ticagrelol, Ticlopidine, Acetylsalicylic acid, dipiridamol, direct thrombin \[factor II\] or factor Xa inhibitors, vitamin-K antagonists).
* Participation in other research study that may influence obtained results.
* Pregnant or breastfeeding women, or expected pregnancy to occur during the study period.
* Treatment of intrastent restenosis/occlusion of previous peripheral vascular stent.
* Non-corrected hemodynamically significant obstructive arterial disease of the ipsilateral inflow arteries (aorta, iliac arteries)
Primary outcome measure(s)
Freedom from major limb amputation — 1 year Number of limbs surviving without above ankle amputation
Target Lesion Revascularization (TLR) — 1 year Number of target lesions requiring re-intervention
MALE - Major Adverse Limb Event — 1 year Composite endpoint Major Amputation, any index limb revascularization
Trial sites (15)
Facility
City
Region
Status
Hospital de Faro - Centro Hospitalar do Algarve
Faro
Algarve
Hospital Divino Espírito Santo
Ponta Delgada
Azores
Hospital Garcia de Orta
Almada
Lisbon District
Centro Hospitalar Tâmega e Sousa
Penafiel
Porto District
Centro Hospitalar Vila Nova de Gaia e Espinho
Vila Nova de Gaia
Porto District
Hospital Santo Espírito Ilha Terceira
Angra do Heroísmo
Terceira
Centro Hospitalar Universitário de Coimbra
Coimbra
Portugal
Hospital da Senhora da Oliveira de Guimarães
Guimarães
Portugal
Hospital de Santa Marta - Centro Hospitalar Lisboa Central
Lisbon
Portugal
Hospital Egas Moniz - Centro Hospitalar Lisboa Central
Lisbon
Portugal
Hospital de Santa Maria - Centro Hospitalar Lisboa Norte
Lisbon
Portugal
Centro Hospitalar Universitário de Santo António
Porto
Portugal
Centro Hospitalar São João
Porto
Portugal
Centro Hospitalar de Trás-os-Montes e Alto Douro
Vila Real
Portugal
Centro Hospitalar Tondela Viseu
Viseu
Portugal
More Hospital do Divino Espírito Santo de Ponta Delgada trials in Portugal
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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