Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand (Tsunami)

Hospital Sao Lucas da PUCRS

Status: Completed

Conditions: Atherosclerotic Heart Disease; Coronary Heart Disease

Treatments: Device: Coronary stent - Tsunami

Study type: Interventional

Funder types: Other

Identifiers

NCT01632501

PCR1TS

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)