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

Coronary Heart Disease Clinical Trial

— Tsunami  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01632501
• Other study ID #: PCR1TS
• Status: Completed
• Phase: N/A
• First received: June 26, 2012
• Last updated: July 2, 2012
• Start date: January 2011

Study information

• Verified date: January 2011
• Source: Hospital Sao Lucas da PUCRS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerotic Heart Disease
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Device:
• Coronary stent - Tsunami
A coronary angioplasty was done

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Lucas da PUCRS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of: need to change the materials during the procedure (angioplasty).		12 months	Yes