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
|Condition or disease||Intervention/treatment||Phase|
|Stents Coronary Artery Disease Angioplasty Humans Coronary Angiography Angioplasty, Balloon, Coronary Treatment Outcome||Device: Stent INC1||Not Applicable|
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)|
|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|
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.
- 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.
- 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.
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
|Contact: Gian Manuel Jiménez Rodríguezfirstname.lastname@example.org|
|Instituto Nacional de Cardiología||Recruiting|
|Mexico City, Mexico, 14080|
|Contact: Gian M Jiménez Rodríguez, Master 5591999962 email@example.com|
|Contact: Arturo Abundes Velasco, Dr firstname.lastname@example.org|
|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|
|Principal Investigator:||Gian Manuel Jiménez Rodríguez||Interventional Cardiology|