The DES We Trust: A Closer Look at the iVascular Angiolite DES, the Coronary Sirolimus Stent Available Through GAP Medical Solutions

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Coronary artery disease remains one of the leading causes of morbidity and mortality worldwide. Percutaneous coronary intervention (PCI) has transformed the treatment of coronary disease, and at the heart of modern PCI sits the drug-eluting stent (DES). Choosing the right stent matters – not just during the procedure itself, but throughout long-term follow-up.

At GAP Medical Solutions, we are proud to distribute the Angiolite sirolimus-eluting coronary stent from iVascular, a device supported by progressive clinical investigation and engineering innovation.

What Is the Angiolite?

The Angiolite is a thin-strut (75µm – 85µm), cobalt-chromium (CoCr) sirolimus-eluting stent manufactured by iVascular in Barcelona, Spain. It features an open-cell design with alternating connectors, laser-cut from CoCr alloy L605 tubing, and coated with a proprietary three-layer fluoroacrylate polymer system known as TransferWise.

The coating is central to the Angiolite platform. Rather than relying on conventional coating methods, iVascular developed a nanodrop deposition process designed to create a homogeneous multilayer coating that delivers sirolimus at approximately 1.4 µg/mm². The result is a biostable, thromboresistant surface intended to support rapid endothelial healing while maintaining a controlled and reliable drug release profile.

Designed for Challenging Anatomy

One of the clinically significant advantages of the Angiolite is its versatility across complex lesion types. The platform is engineered to perform across a broad range of anatomical and lesion characteristics encountered in contemporary PCI practice.

Left Main and Bifurcation Lesions

Angiolite offers high overexpansion capacity, with post-dilatation supported up to 6.00 mm across 4.0–4.5 mm platforms. This may make it suitable for large-vessel work including left main interventions, where adequate vessel coverage without distortion is important.

Small Vessel Disease

With struts measuring 75–85 µm, the Angiolite is adapted to the geometric demands of smaller coronary arteries, where thicker-strut devices may adversely affect healing and flow dynamics.

Diffuse and Long Lesions

Available in lengths up to 44 mm and 49 mm, the Angiolite accommodates diffuse disease without necessarily requiring multiple overlapping stents, potentially reducing the risk of geographic miss and excessive polymer overlap.

Calcified Lesions

According to benchmarking data published by iVascular, the stent platform is designed to provide strong radial support, offering reliable scaffolding in calcified coronary segments where structural integrity is important.

The TransferWise Polymer: Engineering Meets Biology

The fluoroacrylate polymer used in the Angiolite serves two principal functions. First, it acts as a drug carrier, releasing sirolimus in a controlled and homogeneous fashion across the stent surface, with more than 75% elution occurring during the first month. Second, it creates a thromboresistant surface layer associated with high early strut coverage.

This mechanism is intended to support vascular healing and may help reduce the risk of late stent thrombosis – historically one of the major concerns associated with first-generation DES platforms. The coating is designed to maintain its integrity during deployment and long term within the vessel wall while minimising inflammatory response associated with some earlier polymer technologies.

The Clinical Evidence

A device is ultimately judged by its evidence base. Angiolite has undergone a progressive programme of clinical investigation, ranging from first-in-human assessment through to larger real-world registries with long-term follow-up.

The ANCHOR Study

The ANCHOR study was a prospective, multicentre, observational study enrolling 103 patients with de novo coronary lesions, including patients presenting with stable angina, NSTEMI, and elective PCI. Patients were randomised 1:3 to three-month or six-month OCT follow-up. OCT-guided assessment demonstrated high levels of early strut coverage with low rates of malapposition and an in-stent late lumen loss (LLL) of 0.07 mm at six months.

These findings supported further investigation into vascular healing characteristics and the potential feasibility of shorter DAPT strategies, although the study was not designed to establish DAPT recommendations.

Published in: Puri R, et al. Catheterization and Cardiovascular Interventions. 2018;91:435–443.

The ANGIOLITE Randomised Trial

The ANGIOLITE trial was a prospective, randomised, multicentre, non-inferiority trial comparing the Angiolite SES directly against a cobalt-chromium everolimus-eluting stent (EES). A total of 223 patients were randomised 1:1. The primary endpoint was in-stent late lumen loss (LLL) at six-month angiographic follow-up.

Angiolite achieved an LLL of 0.04 mm at six months, meeting non-inferiority criteria versus the EES comparator while also demonstrating numerically lower late lumen loss. OCT assessment of in-stent healing produced findings consistent with the ANCHOR study. Target lesion failure (TLF) was evaluated through 24 months, with outcomes supporting the safety and durability of the Angiolite platform.

Published in: Moreu J, et al. EuroIntervention. 2019.

The RANGO Registry

The RANGO registry provides the most comprehensive real-world dataset currently available for the Angiolite platform. It was a prospective, single-arm, multicentre, multinational observational registry enrolling 654 patients across 16 academic medical centres in Spain and Portugal between June 2017 and July 2018, with 646 patients included in the final analysis.

The population represented a high-risk, real-world cohort: nearly one quarter presented with STEMI, almost half had multivessel disease, and nearly one in five had a prior myocardial infarction.

  • At two years, the registry reported a TLF rate of 3.4%.
  • At three years, results presented at EuroPCR 2022 demonstrated consistent performance across predefined subgroups including patients with diabetes mellitus and those receiving stents in small vessels (≤2.5 mm).
  • At five years, published data from the Angiolite-only cohort demonstrated TLF of 7.7%, target vessel failure (TVF) of 8.7%, and a low rate of definite/probable stent thrombosis of 0.9%.

Published in: Pérez de Prado A, et al. REC: Interventional Cardiology.

Summary of Key Clinical Results

Study Design Key Outcome
ANCHOR Prospective, multicentre, 103 patients High early strut coverage; 0.07 mm LLL at 6 months
ANGIOLITE Trial Randomised, multicentre, 223 patients 0.04 mm LLL at 6 months; non-inferior to EES
RANGO Registry Prospective, real-world, 646 patients 3.4% TLF at 2 years; 0.9% stent thrombosis at 5 years (Angiolite-only cohort)

Why GAP Medical Solutions?

GAP Medical Solutions is a UK-based medical device distributor specialising in interventional vascular and cardiology technologies. We partner with iVascular as one of our core supplier relationships, distributing the Angiolite alongside the broader iVascular coronary portfolio, including the Architect guidewire, Capturer thrombectomy system, and a range of balloon catheters.

We work closely with cath lab teams, procurement departments, and clinical leads to support access to appropriate technologies backed by responsive specialist support and product knowledge.

If you would like to learn more about the Angiolite or any other product in our portfolio, our team is available Monday to Friday, 8.30am to 5.00pm.

T: +44 (0) 1934 53 34 53
E: enquiries@gapmedicalsolutions.com
W: gapmedicalsolutions.com/angiolite

GAP Medical Solutions – Patient First Medical Device Distribution.

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