Cordis has concluded patient enrolment in the SUCCESS PTA post-market study of the SELUTION SLR drug-eluting balloon (DEB) to treat patients with peripheral artery disease (PAD).
The new sirolimus-eluting balloon has been designed to offer controlled and sustained drug release, like a drug-eluting stent.
Collecting ‘real-world’ safety, efficacy, health economics and patient-reported quality-of-life data in more than 700 PAD patients treated with the DEB is the objective of the trial.
The single-arm all-comers study includes all lower limb conditions and will encompass a minimum of 50 sites across Asia, South America and Europe.
Patients will have follow-up assessments at 30 days, six months and annually for up to five years.
Clinically driven target lesion revascularisation at 12 months is the primary endpoint of the trial.
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Major adverse limb events, target limb revascularisation, as well as device and procedure success, are the secondary endpoints.
The SUCCESS PTA Study data will contribute to the clinical evidence used for renewing the CE Mark under the European Medical Device Directive.
Cordis CEO Shar Matin said: “This is the largest and most important study we have done for these BTK and SFA patients to date.
“We are very excited to partner with thought leaders globally to build an extensive compendium of clinical evidence that supports our groundbreaking SELUTION SLR DEB technology.”
The company received CE Mark approval for SELUTION SLR DEB to treat peripheral artery disease in February 2020, as well as for the treatment of coronary artery disease in May of the same year.
SELUTION SLR DEB obtained IDE approval for coronary in-stent restenosis in October last year, followed by IDE approval for de novo coronary artery disease in January this year.