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

NCT03375411 | Withdrawn DMC

• 1 other identifier: 17-1036
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Need of Revascularization

  9 months

• MACE

  9 months

• Hyperplasia

  9 months

Study Arms (1)

INC1-Bare metal stent

EXPERIMENTAL

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

Device: Stent INC1

Interventions

Stent INC1 DEVICE

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

INC1-Bare metal stent

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead
• GSE Biomedical: collaborator
• Medstent SA de CV.: collaborator

Study Sites (1)

Instituto Nacional de Cardiología

Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Gian Manuel Jiménez Rodríguez

  Interventional Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical investigator assistant

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: December 18, 2017
• Study Start: December 30, 2017
• Primary Completion: November 15, 2018
• Study Completion: January 25, 2019
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)