Recruitment of patients for iVascular’s ANCHOR clinical trial has been completed with 104 patients treated with the sirolimus eluting stent Angiolite. The first interim three-month data have been presented at EuroPCR Congress 2016.
Coordinated by principal investigator Josep Rodés-Cabau from Quebec Heart and Lung Institute, Canada, the objective of the ANCHOR clinical trial is to perform a prospective assessment of feasibility, exploratory efficacy and clinical performance of the Angiolite sirolimus-eluting stent, using intracoronary optical coherence tomography (OCT).
One-hundred and four patients with de novo lesion, including those with chronic stable angina, acute coronary syndrome (NSTEMI) or in the setting of elective PCI have been included. An adaptive design of the study has randomized patients to either three-month or six-month angiographic/OCT follow-up. Clinical follow-up will occur at 30 days, three months, six months, 12 months and 24 months post-PCI.
The interim analysis at three-month follow-up shows the following OCT-measured results: out of a total of 5892 struts analysed, 89.1%±19% of covered struts, with neointimal area obstruction of only 6.1%±8.6%. The incomplete strut apposition rate (ISA) is 0.97%. This OCT results are supported by angiographic values of LLL=0.07±0.23 mm and 0% binary restenosis.
As stated by Rodés-Cabau, “The main purpose of ANCHOR trial is to confirm and broaden Angiolite’s efficacy and safety results obtained in preclinical models. The results of ANCHOR trial will allow direct comparison to other already published studies applying DES in the same target vessels. First interim data at three months is showing a high rate of covered struts with minimal neointimal hyperplasia and a very low incidence of strut malapposition”
Angiolite is a sirolimus (1,4 µg/mm2) eluting stent on a L605 CoCr platform struts of 80 µm. The distal part of the catheter is coated with a proprietary durable hydrophilic coating, designed to minimise friction and improve its trackability. Stent sizes comprise diameters from 2.0 to 4.5mm and lengths from 9 to 39mm. Combining extra-low profile with effective proven drug eluting coating technology, is intended to contribute to procedure cost reduction.