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First-in-Man Study: Safety and Efficacy of INC-1 Bare Metal Stent in the Novo Coronary Lesions.

NCT03375411 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-10-07

No results posted yet for this study

Summary

This is a First In Man study with the aim to know the safety and effectiveness of a novel bare metal stent (INC-1) in the treatment of de novo coronary lesions in patients with stable coronary angina and unique coronary lessions.

Conditions

  • Stents
  • Coronary Artery Disease
  • Angioplasty
  • Humans
  • Coronary Angiography
  • Angioplasty, Balloon, Coronary
  • Treatment Outcome

Interventions

DEVICE

Stent INC1

Coronary intervention with conventional angioplasty technique but with a novel bare metal stent.

Sponsors & Collaborators

  • GSE Biomedical

    collaborator OTHER

  • Medstent SA de CV.

    collaborator UNKNOWN

  • Instituto Nacional de Cardiologia Ignacio Chavez

    lead OTHER

Principal Investigators

  • Gian Manuel Jiménez Rodríguez · Interventional Cardiology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-12-30
Primary Completion
2018-11-15
Completion
2019-01-25

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 NCT03375411 on ClinicalTrials.gov