NCT03263260

Brief Summary

Post-marketing, prospective, multicentric, non-randomized registry to evaluate the safety and efficacy of Inspiron Sirolimus Eluting Coronary Stent at the treatment of "real-world" patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,504

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 2, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2024

Completed
Last Updated

September 4, 2024

Status Verified

September 1, 2024

Enrollment Period

5.5 years

First QC Date

August 24, 2017

Last Update Submit

September 2, 2024

Conditions

Coronary Artery Disease

Keywords

stent, DES, Inspiron

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiac Events Rate

    Cardiac Death, MI, Target Lesion Revascularization and Stent Thrombosis

    12 months

Secondary Outcomes (2)

  • Target Vessel and Lesion Revascularization Rates

    24 months

  • Stent Thrombosis Rate

    24 months

Study Arms (1)

implanted patients

Patients with native coronary artery lesions with diameter between 2.5 and 4.0 and 34 mm of length treated only with the Inspiron Sirolimus eluting Stent

Device: implant

Interventions

implantDEVICE

coronary stent implantation

implanted patients

Eligibility Criteria

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

Patients older than 18 years submitted to implant of the Inspiron Sirolimus Eluting Stent in native coronary arteries

You may qualify if:

  • alll patients that have been treated with the Inspiron Sirolimus Eluting Stent older and 18 years

You may not qualify if:

  • Safein Vein or Left Internal Mammary artery Grafts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

União Brasileira de Educação e Assistência - Hospital São Lucas da PUC - RS

Porto Alegre, Rio Grande do Sul, 90.619-900, Brazil

Location

MeSH Terms

Conditions

Coronary Artery DiseaseDysequilibrium syndrome

Interventions

Mutagenesis, Insertional

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Protein EngineeringGenetic EngineeringGenetic TechniquesInvestigative TechniquesMutationGenetic VariationGenetic PhenomenaMutagenesis

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 28, 2017

Study Start

June 2, 2017

Primary Completion

December 15, 2022

Study Completion

January 21, 2024

Last Updated

September 4, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)