First-in-Man Study: Safety and Efficacy of INC-1 Bare Metal Stent in the Novo Coronary Lesions.

Instituto Nacional de Cardiologia Ignacio Chavez

Overview

This is a First In Man study with the aim to know the safety and effectiveness of a novel bare metal stent (INC-1) in the treatment of de novo coronary lesions in patients with stable coronary angina and unique coronary lessions.

The cost of performing a percutaneous coronary intervention is very variable since a large number of materials and human resources are considered, with the Stent cost being a fundamental factor; in developing countries, the cost this technology represents an important expense for the patient and the health system; which promotes the development of local technology to support the requirement of these devices. Ischemic heart disease together with cerebral vascular events is the main cause of, adding 15 million deaths per year. Percutaneous revascularization is the gold standard choice in many of the variants of presentation of ischemic heart disease, the implantation of Stents is the most used method. Nowadays more and more countries start their own research and development of novel devices in order to reduce cost. Research question: Is the INC1 Bare Metal Stent safe and effective for the treatment of de novo coronary lesions in humans? Hypothesis: The INC1 Bare-metal Stent is safe and effective for the treatment of de novo coronary lesions in humans The INC1 Bare metal Stent is a 70uCoCr

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Stents Coronary Artery Disease Angioplasty Humans Coronary Angiography Angioplasty, Balloon, Coronary Treatment Outcome

Interventions

Stent INC1DEVICE

Coronary intervention with conventional angioplasty technique but with a novel bare metal stent.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Both genders. * From 18 to 75 years * Stable ischemic heart disease. * Live less than 300 km from the Institution * Single coronary artery disease with a single coronary lesion * Stenosis of 50 to 90% of the lumen of the vessel to be treated. * Lesions less than 20 mm long * Reference lumen of the vessel to be treated greater than 2.5mm and less than 4.5mm Exclusion Criteria: * Left main disease. * Lesions greater than 90% of the lumen. * Non-dilatable lesion with conventional balloons. * Contraindication for dual antiplatelet therapy. * Creatinine clearance less than 45ml / min. * Calcification from moderate to severe. * Multivessel coronary artery disease. * Chronic total occlusion. * Cardiogenic shock or hemodynamic instability. * Left ventricular ejection fraction less than 30%. * Valvular disease of moderate to severe. * Coronary disease in bifurcation. * Probable or definite presence of thrombus in the lesion.

Locations (1)

Instituto Nacional de Cardiología

Mexico City, Mexico

Outcomes

Primary Outcomes

Incidence of late lumen loss [Safety and Tolerability])

The primary endpoint of the study is angiographic in-stent late lumen loss (LLL), defined as the difference between the post-procedural minimal lumen diameter (MLD) in the stented segment and the MLD in the same segment at follow-up measured by the angiography laboratory.

Time frame: 9 months

Secondary Outcomes

Need of Revascularization

The Need of Revascularization of the treated vessel with a new angioplasty

Time frame: 9 months

MACE

To evaluate the presence of major adverse cardiovascular events such (MACE) as cardiac death, myocardial infarction, new angina event or revascularization through surgery.

Time frame: 9 months

Hyperplasia

To evaluate the degree of neointimal hyperplasia or at 9 months by intracoronary ultrasound.

Time frame: 9 months

Data from ClinicalTrials.gov

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