EFFPAC Trial

EFFPAC is a multicenter, randomized and controlled trial to assess the EFFectiveness of luminor PAClitaxel-coated balloon catheter versus uncoated balloon catheter in the superficial femoral and popliteal arteries to prevent vessel restenosis or reocclusion.

Device: luminor 35

Number of patients: 171

Follow up: 24-month

Type of lesions: Femoropopliteal arteries, lesions TASC A & B

1. Teichgräber U, et al. Are DCB safe? Not all DCBs are the same. New data: EFFPAC 2-year safety and efficacy. Presented in EuroPCR 2019, Paris. 2. Laird JR, et al. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol. 2015 Dec 1;66(21):2329-2338. 3. Scheinert D, et al. The LEVANT I (Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis) Trial for Femoropopliteal Revascularization: First-in-Human Randomized Trial of Low-Dose Drug-Coated Balloon Versus Uncoated Balloon Angioplasty. JACC: cardivascular Intervention. Vol. 7, No.1, 2014. 4. Albrecht T, et al. Two-Year Clinical Outcomes of the CONSEQUENT Trial: Can Femoropopliteal Lesions be Treated with Sustainable Clinical Results that are Economically Sound? Cardiovasc Intervent Radiol (2018) 41: 1008. 5. Brodmann M, et al. ILLUMENATE European Randomized Trial: 2-Year Results. Presented at LINC 2019, Leipzigh.

The luminor paclitaxel-coated balloon catheter demonstrates to be clinical highly effective and safe in inhibiting restenosis compared to POBA.

The innovative coating technique matters and is shown not only in the patency, LLL and TLR data, but also in the safety outcomes. The results of the study allow direct comparison to other already-completed RCTs applying Paclitaxel-coated DEB from different manufacturers in the same target vessels.

EFFPAC 24-month has been presented at EuroPCR 2019.

Prof. U. Teichgräber  – Hospital University of Jena (Jena, DE)

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