NCT03471234

Brief Summary

Prospective, multicenter, single arm registry to monitor post-market clinical outcomes of patients treated with Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
299

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

March 5, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

September 3, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2022

Completed
Last Updated

May 18, 2023

Status Verified

April 1, 2023

Enrollment Period

2.2 years

First QC Date

March 5, 2018

Last Update Submit

May 17, 2023

Conditions

Coronary Artery Disease

Keywords

coronary diseasedrug eluting stentInspiron

Outcome Measures

Primary Outcomes (1)

  • MACE (major cardiac events)

    Major cardiac events (death, myocardial infarction, target vessel revascularization)

    12 months

Secondary Outcomes (3)

  • Acute success

    up to 24 hours

  • Stent Thrombosis

    24 months

  • MACE

    24 months

Interventions

AngioplastyDEVICE

Inspiron Drug Eluting stent implantation

Eligibility Criteria

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

Patients with lesions in native coronary arteries measuring between 2.5 and 4.0 mm in diameter and 34 mm length treated only with Inspiron Sirolimus-Eluting Stent.

You may qualify if:

  • All individuals aged over 18 years who signed the informed consent and had lesions in native coronary arteries treated only with Inspiron Sirolimus-Eluting stent.

You may not qualify if:

  • Saphenous vein grafts or Mammary lesions;
  • Individuals who have been treated within the last 6 months with another stent;
  • Acute myocardial infarction with ST segment elevation;
  • Chronic Total Occlusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Location

Instituto do Coração - INCOR

São Paulo, Brazil

Location

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary Disease

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 20, 2018

Study Start

September 3, 2018

Primary Completion

October 30, 2020

Study Completion

August 2, 2022

Last Updated

May 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(2)