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Thin Versus Thicker Strut Thickness Stents in Primary Percutaneous Intervention

NCT06914089 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-04-08

No results posted yet for this study

Summary

1. To evaluate clinical safety of the device in terms of Deaths, any stroke and Myocardial Infarction up to 1 year in both study groups to prove non inferiority of biomime stent
2. To evaluate presence of Target lesion and target vessel revascularization in in both study groups prove non inferiority of biomime stent
3. To evaluate target vessel non-target lesion revasularization in both study groups prove non inferiority of biomime stent

Conditions

  • Primary Percutaneous Coronary Intervention

Interventions

DEVICE

The BioMime is an ultra-thin strut (65 µm) SES that uses a cobalt-chromium platform with a unique hybrid design of open cells in the mid segment and closed cells at the edges

testing its safety and efficacy at long term follow up after primary percutaneous intervention

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Magdy algowhary, MD · Assiut University Heart Hospital, Department of Cardiology, Assiut University, Assiut, Egypt.

  • Salwa R Demitry, MD · Assiut University Heart Hospital, Department of Cardiology, Assiut University, Assiut, Egypt.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-09-30
Completion
2023-09-30

Countries

  • Egypt

Study Locations

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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 NCT06914089 on ClinicalTrials.gov