The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry) (NCT06416644) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)
Portugal100 participantsStarted 2023-04-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 diseas…
What they're measuring
1
Freedom from major limb amputation
Timeframe: 1 year
2
Target Lesion Revascularization (TLR)
Timeframe: 1 year
3
MALE - Major Adverse Limb Event
Timeframe: 1 year
Trial details
NCT IDNCT06416644
SponsorHospital do Divino EspÃrito Santo de Ponta Delgada