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BioFreedom Pharmacokinetic Study

NCT03365492 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-07-01

No results posted yet for this study

Summary

The purpose of this pharmacokinetic (PK) study is to characterize the maximum concentration (Cmax) and time-to-maximum concentration (Tmax) of Biolimus A9TM and its active metabolites sirolimus and everolimus in a cohort of coronary artery disease (CAD) patients following implantation of BioFreedomTM SS stent.

Conditions

Interventions

DEVICE

BioFreedom™ BA9™ drug-coated stent

Drug-coated stent for coronary arteries

Sponsors & Collaborators

  • Biosensors Europe SA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-12
Primary Completion
2018-04-30
Completion
2018-06-30

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 NCT03365492 on ClinicalTrials.gov