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

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ClinicalTrials.gov Identifier: NCT03375411
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 21, 2017
Sponsor:
Collaborators:
GALAZ SCIENCE AND ENGINEERING SA DE CV
Medstent SA de CV.
Information provided by (Responsible Party):
Gian Manuel Jiménez Rodríguez, Instituto Nacional de Cardiologia Ignacio Chavez

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.

Condition or disease Intervention/treatment Phase
Stents Coronary Artery Disease Angioplasty Humans Coronary Angiography Angioplasty, Balloon, Coronary Treatment Outcome Device: Stent INC1 Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: INCSTENT First-in-Man Study: Safety and Efficacy of INC-1 Bare Metal Stent in the Novo Coronary Lesions.
Estimated Study Start Date : December 30, 2017
Estimated Primary Completion Date : November 15, 2018
Estimated Study Completion Date : January 25, 2019

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.



Primary Outcome Measures :
  1. Incidence of late lumen loss [Safety and Tolerability]) [ Time Frame: 9 months ]
    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.


Secondary Outcome Measures :
  1. Need of Revascularization [ Time Frame: 9 months ]
    The Need of Revascularization of the treated vessel with a new angioplasty

  2. MACE [ Time Frame: 9 months ]
    To evaluate the presence of major adverse cardiovascular events such (MACE) as cardiac death, myocardial infarction, new angina event or revascularization through surgery.

  3. Hyperplasia [ Time Frame: 9 months ]
    To evaluate the degree of neointimal hyperplasia or at 9 months by intracoronary ultrasound.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375411


Contacts
Contact: Gian Manuel Jiménez Rodríguez 5591999962 gianma21@hotmail.com

Locations
Mexico
Instituto Nacional de Cardiología Recruiting
Mexico City, Mexico, 14080
Contact: Gian M Jiménez Rodríguez, Master    5591999962    gianma21@hotmail.com   
Contact: Arturo Abundes Velasco, Dr       abundesva@yahoo.com.mx   
Principal Investigator: Arturo Abundes Velasco, Dr         
Sub-Investigator: Marco A Martínez Ríos, Dr         
Sub-Investigator: Marco A Peña Duque, Dr         
Sub-Investigator: Jorge Gaspar Hernández, Dr         
Sub-Investigator: Guering Eid Lidt, Dr         
Sub-Investigator: Felix Damas de los Santos, Dr         
Sub-Investigator: Yigal Piña Reyna, Dr         
Sub-Investigator: Eduardo Arias Sánchez, Dr         
Sponsors and Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez
GALAZ SCIENCE AND ENGINEERING SA DE CV
Medstent SA de CV.
Investigators
Principal Investigator: Gian Manuel Jiménez Rodríguez Interventional Cardiology

Responsible Party: Gian Manuel Jiménez Rodríguez, Clinical investigator assistant, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier: NCT03375411     History of Changes
Other Study ID Numbers: 17-1036
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases