NCT03401216 - StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 20, 2017

Primary Completion Date

April 30, 2018

Study Completion Date

April 30, 2019

Conditions

Ischemic Heart DiseaseCoronary Artery DiseaseCoronary Atherosclerosis

Interventions

DEVICE

SYNERGY 48 mm

Material: Platinum-Chromium alloy. Stent strut thickness: 0.0029-0.0032 inches. Polymer carrier composed of PLGA (poly(DL-lactide-co-glycolide)). Drug product: Everolimus, 1µg per 1 mm2. Stent diameters available: 2.25; 2.50; 2.75; 3.00; 3.50; 4.00 mm. Stent length: 48 mm. Nominal balloon pressure: 11 atm. (1117 kPa). Manufacturing company: Boston Scientific Corporation (USA)

PROCEDURE

PCI

Standard PCI procedure

PROCEDURE

3 month OCT follow-up

Optical coherence tomography imaging of target vessel within 3 month after PCI

PROCEDURE

6 month OCT follow-up

Optical coherence tomography imaging of target vessel within 5 month after PCI

Trial Locations (1)

630055

RECRUITING

Academician E.N. Meshalkin national medical research center, Novosibirsk