Clinical Evidence

TiTAN OPTIMAX™

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THE TIDES-ACS RANDOMIZED CONTROLLED TRIAL : Key Findings at 60 months

The TIDES-ACS randomized controlled trial is the first trial comparing the new Optimax Titan bioactive stent (Co-Cr platform) against the Best-in-Class 3rd generation Everolimus-Eluting Stent Synergy

THE TIDES-ACS RANDOMIZED CONTROLLED TRIAL : Key Findings at 12 and 18 months

The clinical trial met both its co-primary endpoint of MACE non-inferiority at 12 months and Safety composite superiority at 18 months.

The BASE-ACS randomized controlled trial : Key Findings at 60 months

At a 5-year follow up Titan2 bioactive stent was non inferior to Everolimus eluting stent for the primary endpoint of MACE (14.4% vs 17.8% p<0.001 for non inferiority).

The BASE-ACS randomized controlled trial : KEY FINDINGS AT 12 MONTHS

The clinical trial met its primary endpoint of MACE non-inferiority at 12 months. The TiTAN2 TiNO coated bioactive stent achieved a low 9.6% MACE rate compared to 9.0% for the control group and demonstrated its non inferiority versus Xience DES (p for non-inferiority = 0.001).

The TITAX-AMI Randomized Controlled Trial

The TITAX-AMI randomized controlled trial is a randomized controlled trial comparing the Titan2 bioactive (Stainless steel platform) stent against the leading 1st generation Drug-eluting stent TAXUS, from Boston Scientific in ACS (STEMI/NSTEMI) patients at 12 months and 60 months follow ups.

Randomized Controlled Studies versus Bare Metal Stents

The TiNOX Trial: Randomized comparison of titanium nitride oxide coated stents with bare metal stent.

At 14 days : Excellent Very early neointimal coverage of bioactive stents by optical coherence tomography

At an average of 14.5 days following stent implantation binary stent strut coverage was 96.3%. Based on data of the current report we can consider an even shorter (than 1 month) dual antiplatelet regiment following bioactive stent implantation.

At 2 months : The TiDES-OCT Randomized Trial: Early Vascular Healing after Titanium Nitride Oxide Coated Stent (bioactive stent) versus Everolimus Eluting Stent in patients with ACS

In this randomized controlled trial enrolling 40 patients, at a 2-month follow up neointimal stent strut coverage was nearly complete in the bioactive stent group (TiTAN OPTIMAX, Hexacath) versus the EES group (p<0.001).

At 9 months : BASE-ACS Trial OCT Substudy

The frequency of uncovered stent struts was significantly higher with EES than with bioactive stent (p<0.001) and stent strut malapposition was less common in the bioactive stent group 0.2% versus 4.6% for EES.

The OPTIMAX-OCT Randomized Controlled Trial

In this study 82 patients were randomized to receive either a bioactive stent TiTAN OPTIMAX or a SYNERGY everolimus eluting stent in ACS patients with a follow-up at 1 and 6 months. Bioactive stent strut coverage was faster and more complete compared to EES in patients with ACS.

BASE-ACS Sub-Study Long-Term Outcome in Diabetic Patients

Among 827 patients enrolled in the BASE-ACS Trial, 140 (16.9%) were diabetic. MACE trough 7 years was more frequent in diabetics versus non-diabetics (23.6% vs. 13.7% p=0.003). MACE was not statistically different between the two stent arms but lower in the bioactive stent group (18.5% versus 28%.)

RAYFLOW™

Continuous vs Bolus Thermodilution to Assess Microvascular Resistance Reserve 

This scientific work was a single-center, prospective study enrolling 175 patients with the aim to compare continuous and bolus thermodilution techniques.

Reproducibility of bolus versus continuous thermodilution for assessment of coronary microvascular function in patients with ANOCA

This study aimed to assess the reproducibility of bolus and continuous thermodilution in assessing coronary microvascular function.

The quest for accurate tools to open the black box of the microcirculation: continuous thermodilution and MRR

Scientific discussion about continuous thermodilution to assess microcirculation dysfunction.

Microvascular Resistance Reserve to Assess Microvascular Dysfunction in ANOCA Patients

The aim of this study was to establish the range of normal values for MRR and to determine an optimal cutoff point.

Saline induced coronary hyperemia with continuous intracoronary thermodilution is mediated by intravascular hemolysis

Saline-induced hyperemia through a dedicated intracoronary infusion catheter is associated with hemolysis.

Automation of intracoronary continuous thermodilution for absolute coronary flow and microvascular resistance measurements

The aim of the present study is to validate a new automated procedure versus the originally described one to allow paired resting-hyperemic thermodilution assessment without interruption.

Thermodilution-derived volumetric resting coronary blood flow measurement in humans

This study demonstrates that in addition to hyperaemic flow, continuous thermodilution can quantify absolute resting coronary blood flow; therefore, it can be used to calculate coronary flow reserve (CFR) and microvascular resistance reserve (MRR).

Microvascular Resistance Reserve for Assessment of Coronary Microvascular Function

Microvascular resistance reserve (MRR) as an index specific for the microvasculature, independent of autoregulation and myocardial mass, and based on operator-independent measurements of absolute values of coronary flow and pressure.

Basics of coronary thermodilution

Practical review of bolus and continuous thermodilution for the measurement of coronary flow and microvascular resistance.

Absolute Coronary Blood Flow Measured by Continuous Thermodilution in Patients with Ischemia and Non obstructive Disease

This study aimed to assess the relationship of Q and R with the established CFR/IMR in INOCA patients, to explore the potential of absolute Q, and to predict self-reported angina.

Coronary physiology before and after chronic total occlusion treatment: what does it tell us ?

Why does a patient suddenly present with angina caused by a CTO that has existed for years? How does a stenosis in the donor artery influence CTO blood supply? What kind of improvement can be expected following PCI?

Absolute microvascular resistance by continuous thermodilution predicts microvascular dysfunction after ST-elevation myocardial infarction

The aim of this study was to assess the ability of Rmicro, measured by continuous thermodilution using the RayFlow catheter, to predict microvascular dysfunction in patients with ST-elevation myocardial infarction.

Computed tomographic myocardial mass compared with invasive myocardial perfusion measurement

The aim of the present study was to compare relative territorial-based CTmass assessment with relative flow distribution, which is closely linked to true myocardial mass. In this exploratory study,

Recovery of Absolute Coronary Blood Flow and Microvascular resistance After Chronic Total Occlusion Percutaneous Coronary Intervention 

This study aimed to investigate longitudinal physiological changes in the recanalized coronary chronic total occlusion (CTO) vessel and its dependent myocardium after successful percutaneous coronary intervention (PCI).

Safety of Absolute Coronary Flow and Microvascular Resistance measurements by Thermodilution

Assessment of the microcirculation of the heart has gained interest over recent years. In this safety study 100 patients were enrolled with a follow up scheduled at 30 days and 1 year.

Saline-Induced Coronary Hyperemia Mechanisms and Effects on Left Ventricular Function 

Intracoronary infusion of saline at room temperature through a dedicated RayFlow catheter for coronary thermodilution induces steady-state maximal hyperemia at a flow rate ≥15 mL/min.

Catheter-Based Measurements of Absolute Coronary Blood Flow and Microvascular Resistance 

The aim of the study is to explore the safety, feasibility, and reproducibility of coronary blood flow and R measurements as measured by continuous thermodilution with the RayFlow catheter in humans.

Novel monorail infusion catheter for volumetric coronary blood flow measurement in humans: in vitro validation

The aim of this study is to validate a novel monorail infusion catheter (RayFlow, Hexacath France) for thermodilution-based quantitative coronary flow measurements.