NCT07491107

Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions

National Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Scitech Produtos Medicos SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective is to evaluate the efficacy and safety of the Inspiron™ EVO drug-eluting stent in complex coronary lesions in a real-world population. Patients with symptomatic ischemic heart disease due to lesions in native coronary arteries and restenotic lesions will be treated with the Inspiron™ EVO drug-eluting stent.

Detailed description

Post-marketing, observational, prospective, multi-center, non-randomized, single-arm registry that will include all patients who receive the Inspiron™ EVO stent at participating sites and meet the eligibility criteria. Up to 2,000 patients are expected to be enrolled across 12 research sites in Brazil. Participants' demographic, procedural, and follow-up data will be collected for up to 12 months in this study.

Conditions

• Coronary Artery Disease (CAD)
• Stenosis Coronary
• Small Vessel Ischemic Disease
• Multivessel Coronary Artery Disease
• Calcific Coronary Arteriosclerosis
• Complex Coronary Lesions

Interventions

Type	Name	Description
DEVICE	Inspiron EVO Drug-Eluting Stent	Percutaneous coronary intervention (PCI) using the Inspiron EVO Drug-Eluting Stent, which has a reduced crimped profile, providing greater safety and facilitating lesion crossing. In addition, the design is optimized to provide increased radial strength.

Timeline

• Start date: 2026-04-30
• Primary completion: 2030-04-30
• Completion: 2030-04-30
• First posted: 2026-03-24
• Last updated: 2026-03-30

Locations

1 site across 1 country: Brazil