Therapy Areas: Devices
Concept Medical enrols first patient in Sirolimus in Peripheral Artery Disease trial
9 November 2020 -

Medical device company Concept Medical Inc revealed on Monday that the first patient in the SirPAD (Sirolimus in Peripheral Artery Disease) trial has been enrolled at University Hospital Zurich.

Initiated by Prof Dr med Nils Kucher (also the Principal Investigator) in charge of the Clinic of Angiology at the University Hospital Zurich, Switzerland, SirPAD is the first All-Comer randomized controlled clinical trial (RCT) investigating major adverse limb events in PAD patients with lesions below the inguinal ligament.

Concept Medical stated that SirPAD is investigator-initiated, single-centre, randomized, non-inferiority, open-label clinical trial investigating whether the use of MagicTouch PTA sirolimus-coated balloon catheters in patients with peripheral artery disease of the femoro-popliteal or below-the-knee segment is not inferior to that of uncoated balloon catheters for major clinical outcomes (unplanned major amputation, target limb re-vascularization). Total of 1200 patients are to be randomized 1:1 (600 patients per treatment group).

The company added that the primary objective if the trial is to evaluate whether the use of sirolimus-coated balloon catheters (MagicTouch PTA) is non-inferior to uncoated balloon catheters in infra-inguinal angioplasty to prevent one-year major adverse limb events (MALE), including unplanned major amputation of the target limb and target lesion re-vascularization for critical limb ischemia, in a representative population of patients with PAD ('all-comers'. If the criterion for non-inferiority is confirmed, the study will test whether sirolimus-coated catheters (MagicTouch PTA) are superior to uncoated catheters for important secondary outcomes and for the primary outcome itself according to pre-specified criteria for hierarchical analysis.