Status:
WITHDRAWN
First-in-Man Study: Safety and Efficacy of INC-1 Bare Metal Stent in the Novo Coronary Lesions.
Lead Sponsor:
Instituto Nacional de Cardiologia Ignacio Chavez
Collaborating Sponsors:
GSE Biomedical
Medstent SA de CV.
Conditions:
Stents
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ...
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 de...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03375411
Start Date
December 30 2017
End Date
January 25 2019
Last Update
October 7 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Instituto Nacional de Cardiología
Mexico City, Mexico, 14080