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Randomized "All-comer" Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent

NCT02328898 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1532

Last updated 2018-04-25

No results posted yet for this study

Summary

The study objective is to assess the safety and efficacy of the Permanent Polymer Zotarolimus-Eluting Stent Resolute Integrity™ to the Polymer Free Amphilimus-Eluting Stent Cre8™ compared in an all-comer patient population. 1 month of dual antiplatelet duration will be applied in stable angina pectoris patients. Myocardial infarction patient population will be treated with 12 months of dual antiplatelet therapy.

Conditions

  • Stable Angina Pectoris
  • Acute Coronary Syndrome

Interventions

DEVICE

Cre8 Stent

Comparison of the Resolute Integrity stent with the Cre8 stent.

DEVICE

Resolute Integrity stent

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Pieter R Stella, M.D., PhD · UMC Utrecht, the Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2018-09-30
Completion
2020-09-30

Countries

  • Luxembourg
  • Netherlands

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 NCT02328898 on ClinicalTrials.gov