NCT01844843

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Terumo Europe N.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	TCD-10023 drug eluting stent	Implantation of new drug eluting stent in coronary artery lesions

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2013-05-01
• Last updated: 2019-10-08

Locations

6 sites across 3 countries: France, Germany, Netherlands