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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Disease; Stents; Treatment Outcome; Coronary Angiography; Angioplasty, Balloon, Coronary; Angioplasty; Humans
• Intervention / Treatment: Device: Stent INC1

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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 14080
    • Instituto Nacional de Cardiologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INC1-Bare metal stent; Percutaneous coronary implantation of the device (Stent INC-1) following the standard procedure of stent placement	Device: Stent INC1; Coronary intervention with conventional angioplasty technique but with a novel bare metal stent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need of Revascularization	The Need of Revascularization of the treated vessel with a new angioplasty	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.	9 months
Hyperplasia	To evaluate the degree of neointimal hyperplasia or at 9 months by intracoronary ultrasound.	9 months

Collaborators and Investigators

• Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
• Collaborators: GSE Biomedical; Medstent SA de CV.
• Investigators: Principal Investigator: Gian Manuel Jiménez Rodríguez, Interventional Cardiology

Study record dates

Study Major Dates

• Study Start (Anticipated): December 30, 2017
• Primary Completion (Anticipated): November 15, 2018
• Study Completion (Anticipated): January 25, 2019

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 17-1036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No