NCT03780192

Brief Summary

Evaluate the efficacy of the Inspiron Sirolimus Eluting Stent on bifurcation coronary artery lesions, in order to preserve and not compromize the side branch using the provisional stent technique.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 28, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

December 17, 2018

Last Update Submit

March 16, 2020

Conditions

Bifurcation LesionCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Percentage of Stenosis

    % of stenosis on side branch after stent placement on main vessel

    day 0

Study Arms (1)

Treatment

Bifurcation lesion treatment using provisional stent technique

Device: Inspiron Sirolimus Eluting Stent

Interventions

Inspiron Sirolimus Eluting StentDEVICE

Bifurcation treatment using provisional stent technique

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with bifurcation coronary artery disease with indication for drug eluting implantation.

You may qualify if:

  • Patients with coronary artery disease on bifurcation anatomy with indication of drug eluting stent implantation , on which the side branch is ≥ 2.5 mm diameter and ostial stenosis ≤50% (Medina 1-1-0, 1-0-0, 0-1-0).

You may not qualify if:

  • Acute Myocardial Infarction (STMI);
  • Chronic occlusion;
  • Cardiogenic shock;
  • Ejection fraction ≤ 20%;
  • Thrombocytopenia (≤ 50 mil);
  • DAPT contraindication;
  • Life expectancy of less than 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Marco Wainstein, MD

CONTACT

+555133143537marco.wainstein@hmv.org.br

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Hospital Moinhos de Vento

Study Record Dates

First Submitted

December 17, 2018

First Posted

December 19, 2018

Study Start

February 28, 2019

Primary Completion

February 15, 2021

Study Completion

February 15, 2022

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)