PR86498

ZURICH, Nov. 9, 2020 /PRNewswire=KYODO JBN/ --

    Concept Medical Inc., (https://www.conceptmedical.com/ ) 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 (https://www.conceptmedical.com/press-release/the-worlds-largest-rct-investigating-use-of-magictouch-pta-sirolimus-coated-balloon-for-peripheral-artery-disease-kicks-off-to-a-flying-start/ )

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 (https://www.conceptmedical.com/press-release/the-worlds-largest-rct-investigating-use-of-magictouch-pta-sirolimus-coated-balloon-for-peripheral-artery-disease-kicks-off-to-a-flying-start/ ) is investigator-initiated, single-center, randomized, non-inferiority, open-label clinical

trial investigating whether the use of MagicTouch PTA (https://www.conceptmedical.com/product/magic-touch-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) (https://www.conceptmedical.com/product/magic-touch-pta/ )

is non-inferior touncoated 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)

(https://www.conceptmedical.com/product/magic-touch-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 

    Photo:

https://mma.prnewswire.com/media/1329810/Enrolment_of_the_first_patient_in_the_SirPAD.jpg 

    Logo: https://mma.prnewswire.com/media/1244676/Concept_Medical_Logo.jpg 

    Source: Concept Medical Inc.