PR89598

SIRONA - The world's first and largest RCT comparing Sirolimus V/S Paclitaxel balloon for the treatment of Peripheral Arterial Disease progresses rapidly

JENA, Germany, May 25, 2021 /PRNewswire=KYODO JBN/ --

    Concept Medical Inc. [https://www.conceptmedical.com/ ], focused on

vascular intervention drug delivery devices, releases status updates of SIRONA

Randomized Control Trial (RCT) which compares head-to-head, SIROlimus versus

Paclitaxel Drug-Eluting BallooN Angioplasty in femoropopliteal arterial

diseases (SIRONA).

    SIRONA is the world's first RCT investigating the use of Sirolimus drug

coated balloon (DCB) (MagicTouch PTA

[https://www.conceptmedical.com/product/magic-touch-pta/ ] – Concept Medical)

V/S Paclitaxel DCB for the treatment of femoropopliteal artery disease.

    SIRONA is an Investigator-Initiated and driven, prospective, multi-center,

corelab adjudicated randomized trial to compare and evaluate the safety and

efficacy of Sirolimus Coated balloon versus Paclitaxel Coated Balloon (CE

certified devices) in the treatment of stenosed or occluded lesions in the

superficial femoral artery (SFA), and/or popliteal artery (P1) in Peripheral

Arterial Disease (PAD) patients with Rutherford classification 2 to 4. The

study will enroll a total of 478 patients randomized 1:1 (MagicTouch

PTA:Paclitaxel Coated Balloon) across 30 sites in Germany and Austria. Led by

the Principal Investigator Prof. Dr. Ulf Teichgraber, of Jena University

Hospital, Germany, the study is moving rapidly with 20 patients already

enrolled.

    Lower extremity PAD affects estimated quarter million adults in Europe and

North America and is associated with significant morbidity and mortality, with

atherosclerosis being the main cause. Symptomatic PAD presents as claudication

and can progress into Critical Limb Ischemia (CLI), pointing at 20% mortality

in the first five years and the rate increasing to 50% post five years.

    Percutaneous Transluminal Angioplasty (PTA) with plain old balloon

angioplasty (POBA) has been widely used as the treatment which involves

expansion of the arteries with an uncoated balloon, but with limited success,

as many patients come back with restenotic or occluded lesions. Drug eluting

stents have been used in the past with anti-proliferative drugs which reduces

the neointimal hyperplasia and stenosis to some extent. DCBs have been used to

effectively treat the stenosed SFA with similar drugs (Paclitaxel and Limus

analogues) recently and are becoming the go to option. Currently, the

commercially available DCBs for peripheral arteries are coated with Paclitaxel.

Given all the safety issues with Paclitaxel, there is need to explore other

drugs to replace Paclitaxel.  

    The primary objective of the SIRONA

[https://www.conceptmedical.com/press-release/sirona-rct-update/ ] trial is to

determine the safety and efficacy of Sirolimus Coated Balloon application in

SFA with the primary endpoint of patency at 12 months defined as absence of TLR

or restenosis and primary safety endpoint determined as composite of freedom

from device or procedure related death at 12 months as well as major target

limb amputation. The trial will include all patients with a disease in the SFA

segment either de-novo or restenotic, falling under Rutherford class 2-4 and

suffering from intermittent claudication to CLI.

    In the past, Paclitaxel Coated Balloon has been used, with limited success,

in the treatment of femoropopliteal arteries in PAD. SIRONA trial is currently

the first trial worldwide that is ongoing to collect additional evidence on

patient safety with a head-to-head comparison of Sirolimus Coated Balloon

(MagicTouch PTA [https://www.conceptmedical.com/product/magic-touch-pta/ ]) and

Paclitaxel Coated Balloon. MagicTouch PTA has been assigned a breakthrough

device designation by the US FDA for BTK indication.

    Prof. Dr. Ulf Teichgraber shows his optimism regarding the trial with a

positive note, "I believe that SIRONA will be a game changer trial by giving

new evidence on how to perform PTA following the principle of nothing leaving

behind."

    Photo - https://mma.prnewswire.com/media/1513788/Sirona_Concept_Medical.jpg

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

    Source: Concept Medical