Country for PR: United Kingdom
Contributor: PR Newswire Europe
Friday, July 29 2022 - 23:31
LIMES Randomised Controlled Trial about Sirolimus Coated Balloon in BTK takes the first Stride: patient enrolment started
MÜNSTER, Germany, July 29, 2022 /PRNewswire-AsiaNet/ --

Concept Medical Inc. [], a pioneer in developing 
drug delivery device platforms for vascular intervention, has announced the 
initiation of LIMES trial.

    LIMES (Prospective Multi-Center Randomized Controlled Trial to Evaluate the 
Safety and Efficacy of SiroLIMus Drug Coated Balloon versus Standard 
Angioplasty for the Treatment of Infrapopliteal Occlusions in Patients with 
PEripheral Arterial DiSease) has already enrolled 15 patients, which is 
encouraging as the Company looks to take a leap in the peripheral artery 
disease (PAD) treatment.

    Initiated by the University Hospitals Jena and Leipzig in Germany and led 
by Principal Investigator (PI) Prof. Dr. Ulf Teichgräber alongside Co-PI Prof. 
Thomas Zeller and Prof. Dierk Scheinert, LIMES is a prospective, multicentre, 
randomized controlled trial (RCT) which is designed and aimed to evaluate Magic 
Touch – PTA 0.014" and 0.018" (Concept Medical Inc 
[]) versus POBA (Plain Old Balloon Angioplasty) 
in a head-to-head comparison (1:1). The trial kicked off with the index patient 
enrolled on 31st March 2022 by PD Dr. Nassan Malyar at the University Hospital 
Münster in Germany.

tarted/ ] is set to enroll 230 patients, randomized in 1:1 (Magic Touch-PTA : 
POBA) fashion in currently 19 centres across Germany and Austria. The patient 
population will include patients presenting with documented chronic critical 
limb ischemia (CLI) in the target limb defined as Rutherford clinical category 
(RCC) 4, 5 or 6 aged greater than or equal to 18 years. The study evaluates 
patients with a reference vessel diameter (RVD) greater than or equal to 2 and 
less than or equal to 4.0mm and total occlusions (100% stenosis) of the target 
lesion. There is no minimal lesion length required, no lesion length limitation 
and no limitation in number of used devices. Follow up will be per in-house 
visits at 30 days, 6, 12, 24 and 36 months.

    The RCT will measure the efficacy of sirolimus-coated balloons in a complex 
setting (CLTI) of the PAD segment (located below the P3 segment of the 
popliteal artery to the tibiotalar joint) against the current standard of care, 
making the trial significant and one to look forward to. The study's primary 
endpoints are the composite of limb salvage and primary patency through 6 
months. Adding to the importance of the RCT, the key-secondary safety endpoint 
is the composite of major adverse limb events (MALE) and perioperative death 
(POD) at 30 days. A blinded core lab will assess patency at 6, 12 and 24 months 
by duplex ultrasound and quantitative vascular angiography (QVA) in case of any 

    Prof. Ulf Teichgräber makes a point on why the RCT is valuable in terms of 
DCB intervention in infrapopliteal occlusions, "BTK revascularization deals 
with the most challenging vascular territory in very sick patients. LIMES  
tarted/ ] will solve the question if sirolimus balloon angioplasty has the 
potential to become the future standard of care in BTK interventions," 
following his recent presentation at the LINC 2022.

    The RCT is drawing the attention and interest of the community considering 
the complex patient cohort it will include, and the use of sirolimus-coated 
balloon, which is already proving its worth in SFA against POBA and Paclitaxel 
in multiple RCTs. Magic Touch PTA is the only commercially available sirolimus 
DCB for PAD, which has also been granted Breakthrough Device Designation. 
Paclitaxel raising second thoughts due to the safety concerns raised by the US 
FDA in peripheral treatment, sirolimus is the most sought after and potential 
prospective for the next alternative in PAD treatment. LIMES RCT, evaluating 
the sirolimus-coated balloon in this complex setting will surely add weight and 
value to Magic Touch PTA Sirolimus Coated Balloon as the future of peripheral 

    About MagicTouch PTA

    MagicTouch PTA [ ] 
is the first drug-coated balloon that has been assigned a 'Breakthrough Device 
Designation' by the U.S. Food and Drug Administration (FDA), for the treatment 
of Below-the-knee lesions in PAD. MagicTouch PTA is a CE approved and 
commercially marketed sirolimus-coated balloon, developed using proprietary 
nanolute technology– the drug delivery technology platform of MagicTouch PTA 
balloon, is designed to deliver sub-micron particles of sirolimus to reach the 
deepest layers of the vessel walls.

    About Concept Medical Inc (CMI)

    CMI [ ] is headquartered in Tampa, Florida 
and has operational offices in The Netherlands, Singapore and Brazil and 
manufacturing units in India. CMI specializes in developing drug-delivery 
systems and has unique and patented technology platforms that can be deployed 
to deliver any drug / pharmaceutical agent across the luminal surfaces of blood 


    Source: Concept Medical Inc