Registry for patients receiving Supera stents for lower limb revascularization
The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)
This study is collecting information from patients in Portugal who are getting Supera stents to see how well they work for improving blood flow in the legs and preventing serious complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital do Divino Espírito Santo de Ponta Delgada Academic / other |
| Locations | 15 sites (Faro, Algarve and 14 other locations) |
| Trial ID | NCT06416644 on ClinicalTrials.gov |
What this trial studies
The SupPORT Registry collects real-world data from Portuguese medical centers performing femoral-popliteal revascularization using Supera stents. This prospective, non-randomized registry focuses on evaluating primary endpoints such as limb salvage, target lesion revascularization, and freedom from major adverse limb events over various time points. Secondary endpoints include major cardiovascular events, all-cause mortality, and patency rates. The registry aims to provide insights into the effectiveness and safety of Supera stents in treating symptomatic obstructive peripheral arterial disease.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older with symptomatic obstructive peripheral arterial disease undergoing endovascular revascularization with Supera stents.
Not a fit: Patients with contraindications for anti-thrombotic therapy or those with target lesions not meeting the specified criteria may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance treatment strategies for patients with lower limb ischemia, potentially improving limb salvage rates and overall patient outcomes.
How similar studies have performed: While this registry approach is not novel, similar studies have shown success in evaluating the effectiveness of stent technologies in vascular interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Faro, Algarve and 14 other locations
- Hospital de Faro - Centro Hospitalar do Algarve — Faro, Algarve, Portugal (Not_yet_recruiting)
- Hospital Divino Espírito Santo — Ponta Delgada, Azores, Portugal (Recruiting)
- Hospital Garcia de Orta — Almada, Lisboa, Portugal (Recruiting)
- Centro Hospitalar Tâmega e Sousa — Penafiel, Porto, Portugal (Recruiting)
- Centro Hospitalar Vila Nova de Gaia e Espinho — Vila Nova de Gaia, Porto, Portugal (Recruiting)
- Hospital Santo Espírito Ilha Terceira — Angra do Heroísmo, Terceira, Portugal (Recruiting)
- Centro Hospitalar Universitário de Coimbra — Coimbra, Portugal (Recruiting)
- Hospital da Senhora da Oliveira de Guimarães — Guimarães, Portugal (Recruiting)
- Hospital de Santa Marta - Centro Hospitalar Lisboa Central — Lisboa, Portugal (Not_yet_recruiting)
- Hospital Egas Moniz - Centro Hospitalar Lisboa Central — Lisboa, Portugal (Not_yet_recruiting)
- Hospital de Santa Maria - Centro Hospitalar Lisboa Norte — Lisboa, Portugal (Not_yet_recruiting)
- Centro Hospitalar Universitário de Santo António — Porto, Portugal (Recruiting)
- Centro Hospitalar São João — Porto, Portugal (Recruiting)
- Centro Hospitalar de Trás-os-Montes e Alto Douro — Vila Real, Portugal (Recruiting)
- Centro Hospitalar Tondela Viseu — Viseu, Portugal (Recruiting)
Study contacts
- Study coordinator: Nelson FG Oliveira, MD, PH.D
- Email: Nelson.FG.Oliveira@azores.gov.pt
- Phone: (+351)296203000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.