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Study of Vascular Healing With the Combo Stent Versus the Everolimus Eluting Stent in ACS Patients by Means of OCT

NCT01405287 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-03-24

No results posted yet for this study

Summary

OBJECTIVE It is the objective of the REMEDEE OCT study to assess vascular healing after deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered Sirolimus Eluting Stent) in patients with Acute Coronary Syndrome (ACS) with single de novo native coronary artery lesions ranging in diameter from ≥2.5 mm to ≤3.5 mm and ≤ 20 mm in length.

STUDY DESIGN The REMEDEE OCT study is a prospective, multicenter, randomized study designed to enroll 60 patients with ACS who will be randomized 1:1 to be treated with the Combo stent versus the commercially available everolimus eluting stent (Xience V or Promus). Patients will receive Optical Coherence Tomography (OCT) and Quatitative Coronary Angiography (QCA) follow-up imaging at 60 days post procedure. Clinical follow-up is scheduled at 30, 60, 180, 360 and 540 days. Furthermore, QCA and OCT will also be performed at baseline in all participants of the study.

Conditions

Interventions

DEVICE

PTCA with stent placement

PTCA with stent placement (Drug Eluting Stent)

Sponsors & Collaborators

  • Genae

    collaborator INDUSTRY

  • OrbusNeich

    lead INDUSTRY

Principal Investigators

  • Ulf Landmesser, MD, PhD · University of Zurich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-08-31
Completion
2014-01-31

Countries

  • Belgium
  • Finland
  • Netherlands
  • Switzerland
  • United Kingdom

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 NCT01405287 on ClinicalTrials.gov