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: 3.5 years
Significant clinical and hemodynamic improvement at long-term follow-up vs POBA. Ashtonishing efficacy outcomes vs other similar RCT at 3 and 4 -year follow-up
fTLR
A safe DCB even at long-term follow-up:1
1- Presented at LINC 2021 by Prof. Ulf Teichgräber
2- Y. Soga et al, Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty, J Endovascular Therapies 2020 Dec;27(6):946-955.
3- Presented at LINC 2018 by Dr John Laird
4- Presented at LINC 2020 by Dr Sean P. Lyden
CONCLUSIONS
“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 DCB from different manufacturers in the same target vessels.
EffPac 3.5-year has been presented at LINC 2021 by Prof Ulf Teichgräber.
EffPac Trial
3.5 years follow-up presented at LINC 2021
MAIN INVESTIGATOR
Prof. U. Teichgräber
Hospital University of Jena (Jena, DE)
