MedTrace Logo

Second-generation Drug-eluting Stents in Diabetes

NCT03321032 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1164

Last updated 2021-01-19

No results posted yet for this study

Summary

This is an investigator initiated randomized trial, performed under the auspices of the Spanish Society of Cardiology.

It is a multicenter, international, parallel, randomized 1:1 (amphilimus-eluting stents vs zotarolimus-eluting stents) clinical trial performed exclusively in patients with diabetes mellitus. The study has an "all-comers diabetics" design.

The primary-endpoint is target lesion failure at 1-year follow-up (non-inferiority design) and the co-primary end-point is target lesion failure at 2-years follow-up (superiority-design).

Conditions

Interventions

DEVICE

Polymer-free amphilimus-eluting stents

Cre8 Evo coronary stent system (CID, Saluggia, Italy)

DEVICE

Biolinx Polymer-based zotarolimus-eluting stents

Resolute Onyx coronary stent system (Medtronic, Minneapolis, Minnesota, US)

Sponsors & Collaborators

  • Spanish Society of Cardiology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-12-19
Primary Completion
2021-01-28
Completion
2022-01-28

Countries

  • Spain

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 NCT03321032 on ClinicalTrials.gov