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June 25, 2020

MERLION Study Evaluates Early Outcomes of iVascular's Luminor DCB to Treat TASC C and D Tibial Disease

June 25, 2020—Professor Tjun Tang, MD, presented interim 6-month results from the MERLION study exploring the iVascular Luminor drug-coated balloon (DCB) in infrapopliteal atherosclerotic lesions in chronic limb threatening ischemia (CLTI) patients with a high incidence of diabetes mellitus (DM) and end-stage renal failure (ESRF). The study results included high technical success, 6-month target lesion patency, and amputation free survival (AFS).

The prospective, nonrandomized, single-arm, observational, multicenter MERLION clinical study is evaluating the safety and efficacy of the Luminor DCB for treatment of TASC C and D tibial occlusive lesions in patients presenting with CLTI. Prof. Tang, who is from Singapore General Hospital, reported the findings online during the 2020 Vascular Interventional Advances (VIVA) Late-Breaking Clinical Trial Livestream.

As described in the abstract, the MERLION study's clinical primary endpoints were freedom from major adverse events, which was a composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target lower extremity amputation (LEA) and clinically driven target lesion revascularization (TLR), defined as any reintervention performed for ≥ 50% diameter restenosis of the target lesion after documentation of recurrent clinical symptoms.

In the study, 50 patients (66 atherosclerotic lesions) were treated with 77 Luminor DCB and four iVascular Angiolite drug-eluting stents (DES) for bailout stenting.

Reported patient characteristics included that 94% had DM, 50% had ESRF, 80% were nonsmokers, and 88% presented with Rutherford Score 5 or 6 wounds; 71.2% of lesions treated were de novo, and 60.6% were TASC C lesions. The mean lesion length was 13.7 ± 9.5 cm, and 51.5% were moderately to severely calcified.

In the VIVA presentation, Prof. Tang reported 100% technical success, although 3 of 66 (4.5%) lesions required bailout stenting for severe flow limiting dissections. There were no deaths within 30 days of intervention.

Six-month results included:

  • 86% AFS (three deaths and four major LEA)
  • 78.9% (52 of 57 lesions) target lesion primary patency
  • 91.2% (45 of 57 lesions) freedom from TLR
  • 68.3% Rutherford Score improvement of ≥ 1 categories

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