MedTrace Logo

StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation

NCT03401216 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-01-17

No results posted yet for this study

Summary

The objective of this study is to evaluate the rate of SYNERGY 48 mm stent strut coverage and assess neointimal progression via OCT measurement in patients who underwent PCI.

Conditions

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Meshalkin Research Institute of Pathology of Circulation

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2018-04-30
Completion
2019-04-30

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03401216 on ClinicalTrials.gov