Trials
Search / Trial NCT06416644

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

Supera Vasculomimetic Stent Chronic Limb Threatening Ischemia Chronic Limb Ischemia Superficial Femoral Artery Popliteal Artery

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.

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