OCT Evaluation 3 Months After Sirolimus Eluting Stent Implantation

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Sirolimus Eluting Stent Inspiron; Device: Bare Metal Stent

• Registration Number: NCT02504307
• Lead Sponsor: Scitech Produtos Medicos Ltda

Brief Summary

Prospective, single center, randomized and non-inferiority study, to include up to 60 patients with de novo coronary artery disease. Patients will be followed at 30 days, 3, 6 and 12 months. At 3 months all patients will be submitted to angiographic and OCT evaluation.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2015-07-20
• Study First Posted: 2015-07-21
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-03
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• one or two de novo lesions (> 50% visual estimation)
• lesion diameter between 2.5 and 3.5 mm
• lesion length up to 33 mm.

Exclusion Criteria

• MI within the last 72 hours
• restenotic lesion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inspiron	Sirolimus Eluting Stent Inspiron	Sirolimus Eluting Stent Inspiron
Cronus	Bare Metal Stent	Bare Metal Stent

Primary Outcome Measures

Name	Time	Method
Safety	3 months	Percentage of strut coverage by OCT

Trial Locations

Locations (1)

Instituto Nacional de Cardiologia; 🇧🇷 Rio de Janeiro, RJ, Brazil