MedTrace Logo

Assessment of Stent Malapposition and Neointimal Coverage on Optical coHerence Tomography at Post-procedure and 3 Months After Platinum Chromium Alloy Of the Element™ Stent Implantation

NCT01581515 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-04-20

No results posted yet for this study

Summary

The purpose of this study is to compare the degree of stent malapposition on an immediate optical coherence tomography (OCT) after nominal stent pressure and at a final post-procedure OCT (ANCHOR-I) and the neointimal coverage on 3-months OCT following the intervention with the randomly assigned two drug-eluting stents (DES), PromusTMElementTM stents versus Xience PRIME® stents.

Conditions

Interventions

DEVICE

Promus Element everolimus eluting coronary stent

Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime

DEVICE

Xience Prime everolimus eluting coronary stent

Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Myeong-Ki Hong, MD.PhD. · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • South Korea

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 NCT01581515 on ClinicalTrials.gov