Atherosclerotic Heart Disease, Coronary Heart Disease
Conditions
Brief summary
The freedom of choice in medicine is based on the physician's ability to treat their patients with the best available therapy. The armamentarium for percutaneous intervention is frequently determined on the basis of subjective criteria and the experience of the interventional cardiologist. The evaluation of devices used in coronary intervention, especially angiography and its clinical outcomes, has rarely been investigated; the exceptions are studies on stents. Therefore, the freedom of choice for the interventional cardiologist has been challenged, especially because of cost restrictions. This way this study aims to assess the safety and efficacy of a device of a single brand in performing percutaneous transluminal coronary angioplasty (guide catheters, guidewires, balloons, and stents) in selected patients.
Interventions
DEVICECoronary stent - Tsunami
A coronary angioplasty was done
Sponsors
Hospital Sao Lucas da PUCRS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The study included both male and female patients for stent implantation referred for angioplasty of coronary arteries with more than 18 years.
Exclusion criteria
* chronic total occlusion angioplasty, * saphenous graft angioplasty, * bifurcation angioplasty (lateral branch greater than 1.5 mm) * plans to perform angioplasty on more than one vessel during the same procedure * and primary angioplasty in acute myocardial infarction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of: need to change the materials during the procedure (angioplasty). | 12 months |
Outcome results
None listed