OCT Evaluation 3 Months After Sirolimus Eluting Stent Implantation

Randomized Evaluation of Vascular Healing After Implantation of Sirolimus Eluting Stent Inspiron™ Versus Its Own Bare Metal Version- An OCT Evaluation After 3 Months Follow-up

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02504307

Acronym

Laranjeiras

Enrollment

Registered

2015-07-21

Start date

2015-07-31

Completion date

2017-09-30

Last updated

2018-08-14

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

Conditions

Coronary Artery Disease

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.

Interventions

DEVICESirolimus Eluting Stent Inspiron

Angioplasty with Sirolimus Eluting Stent Inspiron implantation

DEVICEBare Metal Stent

Angioplasty with Bare Metal Stent Cronus implantation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety	3 months	Percentage of strut coverage by OCT

Countries

Brazil

Outcome results

None listed

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