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

NCT ID: NCT03375411

Last Updated: 2022-10-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-30
• Study Completion Date: 2019-01-25

Brief Summary

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.

Detailed Description

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

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

INC1-Bare metal stent

Percutaneous coronary implantation of the device (Stent INC-1) following the standard procedure of stent placement

Group Type: EXPERIMENTAL

Stent INC1

Intervention Type: DEVICE

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

Interventions

Stent INC1

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GSE Biomedical

OTHER

Sponsor Role: collaborator

Medstent SA de CV.

UNKNOWN

Sponsor Role: collaborator

Instituto Nacional de Cardiologia Ignacio Chavez

OTHER

Sponsor Role: lead

Responsible Party

Gian Manuel Jiménez Rodríguez

Clinical investigator assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gian Manuel Jiménez Rodríguez

Role: PRINCIPAL_INVESTIGATOR

Interventional Cardiology

Locations

Instituto Nacional de Cardiología

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

17-1036

Identifier Type: -

Identifier Source: org_study_id