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Percutaneous Coronary Intervention With the Angiolite Drug-eluting Stent: an Optical Cohenrece Tomography Study

NCT02776267 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-07-17

No results posted yet for this study

Summary

The purpose of this study is to perform a first-in-man assessment of feasibility, exploratory efficacy and clinical performance of the novel Angiolite drug-eluting stent (iVascular, Barcelona, Spain) utilizing intracoronary optical coherence tomography (OCT).

Conditions

Interventions

DEVICE

Angiolite stent

Following index PCI, patients will be followed via scheduled clinic and/or phone contact at 1-, 3-, 6-, 12- and 24-month. Patient will be randomized to undergo a scheduled repeat coronary angiogram and OCT evaluation at either at 3- or 6-month post index PCI.

Sponsors & Collaborators

  • iVascular

    collaborator UNKNOWN

  • Josep Rodes-Cabau

    lead OTHER

Principal Investigators

  • Josep Rodes-Cabau, MD · Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-06-30
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 NCT02776267 on ClinicalTrials.gov