MedTrace Logo

EluNIR Ridaforolimus Eluting Coronary Stent System in Patients at High Bleeding Risk (HBR)- EluNIR HBR Study

NCT03877848 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 319

Last updated 2021-09-01

No results posted yet for this study

Summary

The study will enroll approximately 316 subjects with a wide spectrum of PCI indications (stable angina as well as ACS), who are considered to be at high risk of bleeding. Patients will undergo PCI with implantation of the EluNIR stent, followed by shortened duration (1 months in stable patients, and up to 3 months in ACS patients) of DAPT.

Conditions

  • Coronary Stenosis

Interventions

DEVICE

Percutaneous Coronary Intervention (PCI)

Patients enrolled to the study will undergo angiography followed by PCI according to current guidelines.

Sponsors & Collaborators

  • Medinol Ltd.

    lead INDUSTRY

Eligibility

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

Timeline & Regulatory

Start
2019-05-06
Primary Completion
2021-06-10
Completion
2021-06-10
FDA Device
Yes

Countries

  • Israel

Study Locations

More Related Trials

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 NCT03877848 on ClinicalTrials.gov