Clinical trial NCT03375411: First-in-Man Study: Safety and Efficacy of INC-1 Bare Metal Stent in the Novo Coronary Lesions.
Official title: INCSTENT First-in-Man Study: Safety and Efficacy of INC-1 Bare Metal Stent in the Novo Coronary Lesions.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stents
Coronary Artery Disease
Angioplasty
Humans
Coronary Angiography
Angioplasty, Balloon, Coronary
Treatment Outcome
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
Collaborators: name: GSE Biomedical
name: Medstent SA de CV.
First posted: 2017-12-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Incidence of late lumen loss [Safety and Tolerability])
timeFrame: 9 months
Secondary outcomes:
measure: Need of Revascularization
timeFrame: 9 months
measure: MACE
timeFrame: 9 months
measure: Hyperplasia
timeFrame: 9 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cardiología
Study officials:
affiliation: Interventional Cardiology
name: Gian Manuel Jiménez Rodríguez
role: PRINCIPAL_INVESTIGATOR
References: