OCT Evaluation 3 Months After Sirolimus Eluting Stent Implantation (Laranjeiras)

Scitech Produtos Medicos

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: Sirolimus Eluting Stent Inspiron; Device: Bare Metal Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT02504307

Laranjeiras

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Inspiron

Experimental group

Description:

Sirolimus Eluting Stent Inspiron

Treatment:

Device: Sirolimus Eluting Stent Inspiron

Cronus

Active Comparator group

Description:

Bare Metal Stent

Treatment:

Device: Bare Metal Stent