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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:
GSE Biomedical
Medstent SA de CV.
Information provided by (Responsible Party):
Gian Manuel Jiménez Rodríguez, Instituto Nacional de Cardiologia Ignacio Chavez

Tracking Information
First Submitted Date  ICMJE October 30, 2017
First Posted Date  ICMJE December 18, 2017
Last Update Posted Date December 21, 2017
Estimated Study Start Date  ICMJE December 30, 2017
Estimated Primary Completion Date November 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03375411 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2017)
  • Need of Revascularization [ Time Frame: 9 months ]
    The Need of Revascularization of the treated vessel with a new angioplasty
  • 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.
  • Hyperplasia [ Time Frame: 9 months ]
    To evaluate the degree of neointimal hyperplasia or at 9 months by intracoronary ultrasound.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First-in-Man Study: Safety and Efficacy of INC-1 Bare Metal Stent in the Novo Coronary Lesions.
Official Title  ICMJE INCSTENT First-in-Man Study: Safety and Efficacy of INC-1 Bare Metal Stent in the Novo Coronary Lesions.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stents
  • Coronary Artery Disease
  • Angioplasty
  • Humans
  • Coronary Angiography
  • Angioplasty, Balloon, Coronary
  • Treatment Outcome
Intervention  ICMJE Device: Stent INC1
Coronary intervention with conventional angioplasty technique but with a novel bare metal stent.
Study Arms  ICMJE Experimental: INC1-Bare metal stent
Percutaneous coronary implantation of the device (Stent INC-1) following the standard procedure of stent placement
Intervention: Device: Stent INC1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 12, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 25, 2019
Estimated Primary Completion Date November 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gian Manuel Jiménez Rodríguez 5591999962 gianma21@hotmail.com
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03375411
Other Study ID Numbers  ICMJE 17-1036
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gian Manuel Jiménez Rodríguez, Instituto Nacional de Cardiologia Ignacio Chavez
Study Sponsor  ICMJE Instituto Nacional de Cardiologia Ignacio Chavez
Collaborators  ICMJE
  • GSE Biomedical
  • Medstent SA de CV.
Investigators  ICMJE
Principal Investigator: Gian Manuel Jiménez Rodríguez Interventional Cardiology
PRS Account Instituto Nacional de Cardiologia Ignacio Chavez
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP