Home > Riviste > Italian Journal of Vascular and Endovascular Surgery > Fascicoli precedenti > Italian Journal of Vascular and Endovascular Surgery 2018 December;25(4) > Italian Journal of Vascular and Endovascular Surgery 2018 December;25(4):302-8

ULTIMO FASCICOLO
 

JOURNAL TOOLS

eTOC
Per abbonarsi
Sottometti un articolo
Segnala alla tua biblioteca
 

ARTICLE TOOLS

Publication history
Estratti
Permessi
Per citare questo articolo

 

ORIGINAL ARTICLE   

Italian Journal of Vascular and Endovascular Surgery 2018 December;25(4):302-8

DOI: 10.23736/S1824-4777.18.01369-4

Copyright © 2018 EDIZIONI MINERVA MEDICA

lingua: Inglese

Early results for the Chocolate Touch paclitaxel-coated PTA balloon catheter for the treatment of femoropopliteal lesions

Gary BINYAMIN 1, Kristine OROSZ 2, Eitan KONSTANTINO 1, Andrew HOLDEN 2

1 TriReme Medical LLC, Pleasanton, CA, USA; 2 Department of Interventional Radiology, Auckland City Hospital, Auckland, New Zealand



BACKGROUND: Plain old balloon angioplasty for peripheral artery occlusive disease is limited by residual stenosis and flow-limiting dissection in the short term and re-stenosis in the mid-term. A number of strategies have been developed to deal with these issues, including stents and drug-eluting technologies.
METHODS: The early clinical experience with the Chocolate Touch paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter is reported in the prospective, single arm, multi-center ENDURE Trial. This technology combines a different method of angioplasty using the nitinol constrained Chocolate balloon with paclitaxel elution. Seventy lesions in femoro-popliteal arteries in 67 patients were treated, with a mean lesion length of 7.3 cm and moderate or severe calcification in 54.3% of cases. The vast majority of patients were Rutherford 3 claudicants.
RESULTS: Acute outcomes were excellent with no flow-limiting dissections after Chocolate Touch treatment and a residual stenosis (>50% diameter loss) in only one case. Most cases (88.6%) had a residual stenosis <30%, often with “stent-like” appearances. The primary endpoint, angiographically measured late lumen loss at 6 months, was only 0.16 mm. Primary patency, as assessed by the core laboratory adjudicated duplex ultrasound was 89.3% at 6-months and 82% at 12 months. Sustained clinical benefit was also seen with 76.3% of patients having an increase in ABI of at least 0.1 from baseline and a decrease in Rutherford score of 1 or more from baseline at 12 months.
CONCLUSIONS: The ENDURE study demonstrates that the addition of a paclitaxel coating to the Chocolate Touch paclitaxel-coated PTA balloon catheter combines the procedural advantages of the device (including very low incidence of significant dissection) with the long-term benefits of a drug-coated balloon.


KEY WORDS: Balloon angioplasty - Endovascular procedures - Peripheral vascular diseases - Peripheral arterial disease - Femoral artery

inizio pagina