Prospective randomised trial evaluating a paclitaxel-coated balloon in patients treated with endothelial progenitor cell capturing stents for de novo coronary artery disease

Abstract

NCT00732953.

A Randomized, Multicenter, Single-Blinded Trial Comparing Paclitaxel-Coated Balloon Angioplasty With Plain Balloon Angioplasty in Drug-Eluting Stent Restenosis

“…Quantitative coronary angiography. Angiographic measurements were done with the CAAS version 5.7 software (Pie Medical Imaging, Maastricht, the Netherlands) in the core lab of the University of Ulm, Ulm, Germany (4,7). The core lab was blinded to the randomized treatment strategy.…”

Prospective ‘real world’ registry for the use of the ‘PCB only’ strategy in small vessel de novo lesions

“…One study was conducted on patients with diabetes,8 one on small vessel disease,9 and one on bifurcation lesions 10. In addition, PCBs were studied with and without the additional implantation of stents coated with endothelial progenitor cells 11. PCBs demonstrated favourable LLL in all of these studies.…”

Paclitaxel-coated balloon plus bare-metal stent for de-novo coronary artery disease

“…Patients were scheduled for angiographic follow-up at 6 months for analysis of the primary endpoint, which was in-stent late loss [10]. To evaluate the long-term impact of PCB in BMS for the treatment of de-novo lesions, patients were clinically followed after 12, 24, 36, 48, and 60 months as determined in the initial study protocol (http://www.clinicaltrials.gov; NCT 00732953).…”

“…In the prospective, multicenter, single-blind, randomized PERfECT Stent trial [10], we evaluated the long-term effect (5 years) of paclitaxel-coated balloon (PCB) plus BMS compared with BMS for the treatment of de-novo coronary artery disease.…”