Concept Medical Inc., focused on vascular intervention drug delivery devices, has announced the enrolment of the first patient in the SirPAD (Sirolimus in Peripheral Artery Disease) trial.
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.
SirPAD is investigator-initiated, single-center, 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 primary objective 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.
The index patient was successfully enrolled on 3rd November 2020 in University Hospital Zurich.
The study is initiated by Prof. Dr. med Nils Kucher (also the Principal Investigator) in charge of the Clinic of Angiology at the University Hospital Zurich, Switzerland.
Prof. Dr. med Nils Kucher was excited to initiate the study and 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-vascularization. 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. Indeed, these trials adopted surrogate (and rather subjective) outcomes as the primary outcome, such as vessel patency and target limb re-vascularization, 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 non-subjective 'hard' outcomes (major amputation and target lesion re-vascularization for critical limb ischemia), of sirolimus-coated vs. uncoated balloon angioplasty for peripheral artery disease in patients."
www.conceptmedical.com
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The US FDA, on the 24th of May 2023, granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's Sirolimus Coated Balloon (SCB) MagicTouch PTA for the treatment of Superficial Femoral Arteries (SFA). This marks the fourth IDE approval for the Company's Sirolimus coated balloon. The Company has already received three other pivotal IDE approvals for its SCB MagicTouch family of products for the coronary In-Stent Restenosis (ISR), Coronary Small Vessel and Below-the-Knee