Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand
- Conditions
- Atherosclerotic Heart DiseaseCoronary Heart Disease
- Registration Number
- NCT01632501
- Lead Sponsor
- Hospital Sao Lucas da PUCRS
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
The study included both male and female patients for stent implantation referred for angioplasty of coronary arteries with more than 18 years.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Occurrence of: need to change the materials during the procedure (angioplasty). 12 months
- Secondary Outcome Measures
Name Time Method