The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)
Launched by HOSPITAL DO DIVINO ESPÍRITO SANTO DE PONTA DELGADA · May 12, 2024
Trial Information
Current as of February 18, 2025
Recruiting
Keywords
ClinConnect Summary
The SupPORT Registry is a clinical trial that is collecting information from patients in Portugal who are receiving a specific type of treatment called femoral-popliteal revascularization. This treatment involves using Supera® stents to help improve blood flow in the leg arteries for people suffering from serious conditions like lower limb ischemia and peripheral arterial disease. The goal of the registry is to gather valuable real-world data about how well this treatment works in everyday clinical settings.
To participate in the study, patients need to have symptoms of obstructive peripheral arterial disease and be undergoing the Supera® stent procedure in either the superficial femoral or popliteal arteries. Participants should be willing to commit to being part of the registry for at least one year and must provide informed consent, meaning they understand what the study involves. However, some individuals may not be eligible if they have certain health conditions or are pregnant. Overall, participants can expect to contribute to important research that could help improve treatments for others with similar health issues in the future.
Gender
ALL
Eligibility 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)
About Hospital Do Divino Espírito Santo De Ponta Delgada
The Hospital do Divino Espírito Santo de Ponta Delgada is a leading healthcare institution located in the Azores, Portugal, dedicated to providing high-quality medical care and advancing clinical research. As a prominent sponsor of clinical trials, the hospital actively engages in innovative studies aimed at enhancing patient outcomes and contributing to the global medical community. With a multidisciplinary team of experienced healthcare professionals and a commitment to ethical standards and patient safety, the hospital fosters a collaborative environment that supports the development of new therapies and interventions across various medical fields.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Porto, , Portugal
Vila Real, , Portugal
Faro, Algarve, Portugal
Ponta Delgada, Azores, Portugal
Almada, Lisboa, Portugal
Penafiel, Porto, Portugal
Vila Nova De Gaia, Porto, Portugal
Angra Do Heroísmo, Terceira, Portugal
Coimbra, , Portugal
Guimarães, , Portugal
Lisboa, , Portugal
Lisboa, , Portugal
Lisboa, , Portugal
Porto, , Portugal
Viseu, , Portugal
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0