Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation

Scitech Produtos Medicos Ltda60 enrolled

Overview

Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.

The first 20 patients enrolled will be evaluated by angiography and Optical Coherence Tomography 3 months after stent implantation. The following 20 patients will be evaluated by the same methods 2 months after the implantation and the last 20 patients after 30 days. All patients will be clinically followed at 30 days, 6 months, 1 and 2 years after index procedure.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Angiography and Optical Coherence Tomography evaluationsDEVICE

coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥18 and ≤ 80years; * Symptomatic CAD or documented myocardial ischemic disease; * Up to 2 de novo lesions on native coronary arteries; * Lesion length ≤ 29mm; * Reference vessel diameter between ≥2.5 and ≤ 3.5 mm; * Stenose at target lesion ≥ 70% and ≤ 99%. Exclusion Criteria: * STEMI within the last 72 hours pre-procedure; * renal insufficiency; * Left Main stenosis \> 50%; * Ostial lesions; * Bifurcation lesions with side branch ≥2mm; * More than one lesion \> 50% at the target vessel; * Left Ejection Fraction less than 30%; * Previous (less than 6 months) PCI at the target vessel.

Locations (5)

Hospital Evangélico do Espírito Santo

Vila Velha, Espírito Santo, Brazil

Hospital do Coração Anis Rassi

Goiânia, Goiás, Brazil

Paraná Medical Research Center

Maringá, Paraná, Brazil

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Outcomes

Primary Outcomes

Tissue Coverage

Change in the tissue coverage percentage measured by OCT

Time frame: 3 months

Secondary Outcomes

in-stent late lumen loss

Time frame: 3 months

Stent Thrombosis

Stent Thrombosis Rates

Time frame: 2 years

Target Vessel Failure

Target Vessel Failure (Death, MI and new revascularization)

Time frame: 2 years

Data from ClinicalTrials.gov

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