Latin America Real World Study With Inspiron Drug Eluting Stent - INSPIRON LATITUDE

LATIn American sTUdy to Investigate the Clinical Performance of Sirolimus-eluting Stent With Abluminal-only bioDEgradable Polymeric Coating (Inspiron TM) in the Treatment of Native Coronary Artery Lesions.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03471234

Acronym

LATITUDE

Enrollment

299

Registered

2018-03-20

Start date

2018-09-03

Completion date

2022-08-02

Last updated

2023-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

coronary disease, drug eluting stent, Inspiron

Brief summary

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

Detailed description

Prospective, multicenter, single arm registry to assess the safety and performance of Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer for the treatment of real world patients.

Interventions

DEVICEAngioplasty

Inspiron Drug Eluting stent implantation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
MACE (major cardiac events)	12 months	Major cardiac events (death, myocardial infarction, target vessel revascularization)

Secondary

Measure	Time frame	Description
Acute success	up to 24 hours	Acute success measured by Angiography after stent implantation
Stent Thrombosis	24 months	Stent Thrombosis rate
MACE	24 months	Major cardiac events (death, myocardial infarction, target vessel revascularization)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026