MedTrace Logo

Randomized Trial Comparing Two Sirolimus-Eluting Stents in Diabetes Mellitus

NCT04660240 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 860

Last updated 2024-02-20

No results posted yet for this study

Summary

Randomized, controlled, blind, single-center and non-inferiority clinical trial to compare the target lesion failure (TLF) at 12 months in patients with diabetes mellitus who underwent percutaneous coronary intervention with an Orsiro stent vs. Abluminus stent.

Conditions

Interventions

DEVICE

Abluminus Sirolimus Eluting Stent System (ASES)

The procedure will be conducted in accordance with the CE mark instructions for use for the ASES. The need or not for postdilation in any segment of the stent will be at the discretion of the operator, seeking its adequate expansion and apposition. To consider PCI to be successful, residual stenosis must be less than or equal to 30% by angiography at the end of the procedure, including the absence of coronary dissection that compromises distal flow or a hemodynamically significant pressure gradient across the lesion.

DEVICE

Orsiro Sirolimus Eluting Coronary Stent System (OSES)

The procedure will be conducted in accordance with the CE mark instructions for use for the OSES. The need or not for postdilation in any segment of the stent will be at the discretion of the operator, seeking its adequate expansion and apposition. To consider PCI to be successful, residual stenosis must be less than or equal to 30% by angiography at the end of the procedure, including the absence of coronary dissection that compromises distal flow or a hemodynamically significant pressure gradient across the lesion.

Sponsors & Collaborators

  • Instituto Nacional de Cardiologia Ignacio Chavez

    lead OTHER

Principal Investigators

  • Guering Eid Lidt, MD · Instituto Nacional de Cardiología Ignacio Chávez

  • Julio I Farjat Pasos, MD MSc · Instituto Nacional de Cardiología Ignacio Chávez

  • Walter O Magaña Ornelas, MD · Instituto Nacional de Cardiología Ignacio Chávez

  • Alejandra D Portillo Romero, MD · Instituto Nacional de Cardiología Ignacio Chávez

  • José A Ayón Martínez, MD · Instituto Nacional de Cardiología Ignacio Chávez

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2025-05-01
Completion
2025-09-01

Countries

  • Mexico

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 NCT04660240 on ClinicalTrials.gov