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.
DESCRIPTION
Device
Luminor 35
Number of patients
171
Follow up
5 years
Type of lesions
Femoropopliteal arteries, lesions TASC A&B
OUTCOMES
High efficacy at long term follow-up: 5 years
Significant clinical and hemodynamic improvement at long-term follow-up vs POBA. Ashtonishing efficacy outcomes vs other similar RCT at 5 -year follow-up
fTLR
Superior Primary Patency over POBA at 5-year
PP
A safe DCB even at long-term follow-up:1
CONCLUSIONS
“EffPac 5 years is one of the few trials demonstrating the efficacy and safety of DCBs at long term follow up.”
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 DCB from different manufacturers in the same target vessels.
EffPac 5-year has been presented at LINC 2022 by Prof Ulf Teichgräber.
MAIN INVESTIGATOR
Prof. U. Teichgräber
Hospital University of Jena (Jena, DE)
