Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand
NCT01632501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2012-07-04
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.
Conditions
- Atherosclerotic Heart Disease
- Coronary Heart Disease
Interventions
- DEVICE
-
Coronary stent - Tsunami
A coronary angioplasty was done
Sponsors & Collaborators
-
Hospital Sao Lucas da PUCRS
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-01-31
- Primary Completion
- 2012-03-31
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