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Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients With Diabetes Mellitus Global

NCT04236609 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3050

Last updated 2023-03-27

No results posted yet for this study

Summary

To compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ sirolimus- eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES). At least 40% of patients are expected to be affected by multivessel coronary artery disease and 30% with acute coronary syndrome

Conditions

Interventions

DEVICE

Abluminus DES+ Sirolimus Eluting Stent System (SES)

The Sirolimus-eluting stent manufactured by Envision and distributed by Concept Medical

DEVICE

XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)

The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA

Sponsors & Collaborators

  • Concept Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Roxana Mehran · Mount Sinai Heart

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2023-10-30
Completion
2024-09-30

Countries

  • Australia
  • Austria
  • Bangladesh
  • Belgium
  • Brazil
  • Czechia
  • France
  • Germany
  • India
  • Ireland
  • Italy
  • Malaysia
  • Mexico
  • Netherlands
  • Poland
  • Singapore
  • South Korea
  • Sweden
  • Switzerland
  • Taiwan
  • 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 NCT04236609 on ClinicalTrials.gov