LIMES Randomised Controlled Trial about Sirolimus Coated Balloon in BTK takes the first Stride: patient enrolment started

Concept Medical Inc.^[1], a pioneer in developing drug delivery device platforms for vascular intervention, has announced the initiation of LIMES trial.

MÜNSTER, Germany, July 29, 2022 /PRNewswire/ -- 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.

Study team at the University Hospital Münster Germany -LIMES RCT - First Patient Enrolled!

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^[2]) versus POBA (Plain Old Balloon Angioplasty) in a head-to-head comparison (1:1). The trial kicked off with the index patient enrolled on 31^st March 2022 by PD Dr. Nassan Malyar at the University Hospital Münster in Germany.

LIMES RCT^[3] 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 ≥18 years. The study evaluates patients with a reference vessel diameter (RVD) ≥2 and ≤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 TLR.

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^[4] 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 intervention.

About MagicTouch PTA

MagicTouch PTA^[5] 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^[6] 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 vessels.

References

1. ^{^} Concept Medical Inc. (www.conceptmedical.com)
2. ^{^} Concept Medical Inc (www.conceptmedical.com)
3. ^{^} LIMES RCT (www.conceptmedical.com)
4. ^{^} LIMES (www.conceptmedical.com)
5. ^{^} MagicTouch PTA (www.conceptmedical.com)
6. ^{^} CMI (www.conceptmedical.com)