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

Coronary Artery Disease Clinical Trial

— LATITUDE  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03471234
• Other study ID #: SCI-CO-01
• Status: Completed
• Start date: September 3, 2018
• Est. completion date: August 2, 2022

Study information

• Verified date: April 2023
• Source: Scitech Produtos Medicos Ltda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: August 2, 2022
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Angioplasty
Inspiron Drug Eluting stent implantation

Locations

Country	Name	City	State
Brazil	Instituto Dante Pazzanese de Cardiologia	São Paulo
Brazil	Instituto do Coração - INCOR	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Scitech Produtos Medicos Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE (major cardiac events)	Major cardiac events (death, myocardial infarction, target vessel revascularization)	12 months
Secondary	Acute success	Acute success measured by Angiography after stent implantation	up to 24 hours
Secondary	Stent Thrombosis	Stent Thrombosis rate	24 months
Secondary	MACE	Major cardiac events (death, myocardial infarction, target vessel revascularization)	24 months