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BiOSS LIM C vs 2nd Generation DES in Non-LM Bifurcations

NCT03548272 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 518

Last updated 2018-07-19

No results posted yet for this study

Summary

Coronary bifurcations are encountered in about 15 - 20% of percutaneous coronary interventions (PCI). They are considered technically challenging and associated with worse clinical outcomes than non-bifurcation lesions. Percutaneous coronary intervention (PCI) to the target bifurcation lesion. Randomization (by means envelope randomization) to investigational device: Group 1 for BiOSS LIM C implantation vs Group 2 for any DES implantation.

Conditions

Interventions

PROCEDURE

Percutaneous Coronary Intervention with stent implantation

PCI with BiOSS LIM C or rDES depending on the randomization

Sponsors & Collaborators

  • Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-12
Primary Completion
2019-06-30
Completion
2020-06-30

Countries

  • Poland

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 NCT03548272 on ClinicalTrials.gov