EICHORCondition: Peripheral Arterial Disease · Sponsor: KANDO Research
The SUPERSURG RCT trial investigates the efficacy and safety of the endovascular treatment of stenosis or restenosis in the common femoral artery (CFA) of patients presenting with Rutherford classification 2,3 or 4 with a Supera Vascular Mimetic Implant of Abbott, compared to classic surgical common femoral artery endarterectomy. The Supera Vascular Mimetic Implant has an interwoven design and has a high crush resistance and is, when correctly implanted, an ideal stent to treat eccentric calcified plaques in the CFA. An expected total of 143 patients will be treated with the Vascular Mimetic Implant of Abbott and compared to a control group of another 143 patients that will be treated with classic surgical endarterectomy of the common femoral artery. Assignment to the treatment groups will be at random. Patients will be invited for a follow-up visit at 1, 6, 12, 24 and 36 months post-procedure. The primary efficacy endpoint is defined as follows: freedom from clinically-driven target lesion revascularization and binary restenosis at 12 months. The primary safety endpoint is defined as follows: a composite of overall death, cardiac, pulmonary, renal complications, sepsis, target lesion revascularisation and wound related complications through 30 days post-index procedure. The secondary endpoints are defined as technical success, primary patency in the deep femoral artery, primary patency in the target lesion, target lesion revascularisation, target vessel revascularisation…
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
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| O.L.V. Hospital | Aalst, Belgium | — |
| Imelda Hospital | Bonheiden, Belgium | — |
| A.Z. Sint-Blasius | Dendermonde, Belgium | — |
| Z.O.L. | Genk, Belgium | — |
| Az Groeninge | Kortrijk, Belgium | — |
| AZ Sint-Maarten | Mechelen, Belgium | — |
| A.Z. Jan Portaels | Vilvoorde, Belgium | — |
| Maastricht UMC+ | Maastricht, Limburg, Netherlands | — |
| Dijklander hospital | Hoorn, North Holland, Netherlands | — |
| St Antonius Hospital | Utrecht, Utrecht, Netherlands | — |
| Noordwest ziekenhuisgroep | Alkmaar, Netherlands | — |
| Bonifraterskie Centrum Medyczne | Krakow, Poland | — |
+ 1 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04349657