Concept Medical, a provider of vascular intervention drug delivery devices, has enroled the first patient in the sirolimus in peripheral artery disease (SirPAD) trial.

The investigator-initiated, single-centre, randomised, non-inferiority and open-label clinical trial will evaluate the use of MagicTouch PTA sirolimus-coated balloon catheters.

The MagicTouch PTA will be evaluated in patients with peripheral artery disease of the femoro-popliteal or below-the-knee segment to verify whether the use of it is not inferior to that of uncoated balloon catheters for major clinical outcomes.

SirPAD trial to assess sirolimus-coated balloon catheter

SirPAD is claimed to be the first All-Comer randomised controlled clinical trial (RCT) designed to assess major adverse limb events in PAD patients with lesions below the inguinal ligament.

Concept Medical will randomise 1200 patients in a 1:1 ratio in the trial. Each treatment group includes 600 patients.

The trial’s primary objective is to assess whether the use of sirolimus-coated balloon catheters is non-inferior to uncoated balloon catheters in infra-inguinal angioplasty to prevent one-year major adverse limb events (MALE) in a representative population of patients with PAD (all-comers).

The adverse limb events include unplanned major amputation of the target limb and target lesion re-vascularisation for critical limb ischemia.

Concept Medical’s study will assess whether MagicTouch PTA is superior to uncoated catheters if the criterion for non-inferiority is confirmed.

The study principal investigator Dr med Nils Kucher said: “Over the past decade, a few RCTs have compared the efficacy and safety of drug-coated (mainly paclitaxel-coated) devices vs. that of uncoated ones, and demonstrated a significant reduction in restenosis rates, late lumen loss, and incidence of target lesion re-vascularisation.

“However, the size of these trials was often too small to draw firm conclusions concerning major clinical outcomes. Moreover, substantial heterogeneity of the study populations and too restrictive eligibility criteria limited their external validity, leading to a difficult interpretation of the results of meta-analyses.”

In August, Concept Medical commenced the patient enrolment in the multi-centre trial, which is designed to evaluate the efficacy of MagicTouch PTA sirolimus coated balloon to treat below the knee (BTK) peripheral artery disease.