November 9, 2020
Enrollment Begins in SirPAD Trial of Concept Medical’s MagicTouch PTA Catheter
November 9, 2020—Concept Medical Inc. announced the enrollment of the first patient in the SirPAD trial, an all-comers randomized controlled clinical trial (RCT) investigating major adverse limb events in peripheral artery disease (PAD) patients with lesions below the inguinal ligament. The study’s index patient was successfully enrolled by Principal Investigator Professor Nils Kucher, MD, at University Hospital Zurich in Switzerland.
According to the company, the investigator-initiated, single-center, noninferiority, open-label clinical trial is evaluating the use of the company’s MagicTouch percutaneous transluminal angioplasty (PTA) sirolimus-coated balloon catheters versus uncoated balloon catheters in patients with PAD of the femoropopliteal or below-the-knee segment for major clinical outcomes (unplanned major amputation, target limb revascularization).
The trial will randomize 1,200 patients 1:1 to treatment with MagicTouch or an uncoated balloon catheter.
Concept Medical stated that the primary objective of SirPAD is to evaluate whether the use of sirolimus-coated balloon catheters (MagicTouch PTA) is noninferior to uncoated balloon catheters in infrainguinal angioplasty to prevent 1-year major adverse limb events (MALEs), including unplanned major amputation of the target limb and target lesion revascularization for critical limb ischemia, in a representative all-comers population of patients with PAD.
If the criterion for noninferiority is confirmed, the study will test whether MagicTouch PTA sirolimus-coated catheters are superior to uncoated catheters for important secondary outcomes and for the primary outcome itself according to prespecified criteria for hierarchical analysis, advised the company.
In Concept Medical’s press release, Prof. Kucher commented, “Over the past decade, a few RCTs have compared the efficacy and safety of drug-coated (mainly paclitaxel-coated) devices versus that of uncoated ones and demonstrated a significant reduction in restenosis rates, late lumen loss, and incidence of target lesion revascularization. However, the size of these trials was often too small to draw firm conclusions concerning major clinical outcomes.”
Prof. Kucher continued, “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. Indeed, these trials adopted surrogate (and rather subjective) outcomes as the primary outcome, such as vessel patency and target limb revascularization, which may be difficult to objectively judge in the setting of an open-label trial, rather than ‘hard’ objective clinical endpoints such as major amputation or urgent revascularization due to critical limb ischemia.”
“The aim of the SirPAD trial is to compare the efficacy, as defined by a composite of clinically relevant nonsubjective ‘hard’ outcomes (major amputation and target lesion revascularization for critical limb ischemia), of sirolimus-coated versus uncoated balloon angioplasty for peripheral artery disease in patients,” advised Prof. Kuchar in the announcement from Concept Medical.