Optical Frequency Domain Imaging (OFDI) Assessed Strut Coverage of New Terumo DES — DISCOVERY123  

Coronary Artery Disease Clinical Trial

Official title: Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent (Development Code TCD-10023) With Biodegradable Polymer at 1, 2 and 3 Months

Status Completed

Clinical Trial Summary

Purpose of this study is to evaluate, after implantation of a drug eluting stent (DES), coverage of the stent struts by new tissue. The evaluation will be performed by means of intravascular imaging technology (optical frequency domain imaging, OFDI). Renewed tissue coverage over the implanted stent struts prevents direct contact between blood and metal/polymer, which could lead to adverse events: patients need to take blood-thinning drugs to prevent these events. Ous new stent has drug and polymer only on the outside of the stent, and the polymer is degraded by the body leaving a bare metal stent after 3-4 months. This should allow fast coverage of the struts, and might allow to reduce duration of the supportive medical treatment. Our hypothesis is that <20% of the struts remain uncovered at 3 months after implantation, as assessed by OFDI.

Clinical Trial Description

We will enroll patients with multiple coronary lesions, which, as is routine practice, will be treated with the new DES in 2 sessions (second one approximately 3-5 weeks after the first one). We will assess lesions by OFDI after the implantation and at the time of 3 months follow-up, when we will ask patients to undergo a coronary angiography. Patients will then have a follow-up contact at 1 year after initial implantation. ;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT01844843
• Study type: Interventional
• Source: Terumo Europe N.V.
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Completion date: June 2016