MedTrace Logo

ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis

NCT02486068 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1670

Last updated 2018-08-14

No results posted yet for this study

Summary

The primary objectives of this trial are:

In patients at high-risk for restenosis,

* To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF) at 1 year
* To assess superiority of the BRS to the EES in TLF between 3 and 7 years

Conditions

  • Coronary Artery Lesion

Interventions

DEVICE

ABSORB scaffold

DEVICE

Xience

Sponsors & Collaborators

  • European Cardiovascular Research Center

    lead NETWORK

Principal Investigators

  • Pieter Smits, MD · Maastad hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-09-28
Primary Completion
2018-08-28
Completion
2024-09-30

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT02486068 on ClinicalTrials.gov