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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01632501
Recruitment Status : Completed
First Posted : July 3, 2012
Last Update Posted : July 4, 2012
Information provided by (Responsible Party):
Denise Oliveira, 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.

Condition or disease Intervention/treatment Phase
Atherosclerotic Heart Disease Coronary Heart Disease Device: Coronary stent - Tsunami Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand
Study Start Date : January 2011
Actual Primary Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty Tsunamis

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

Primary Outcome Measures :
  1. Occurrence of: need to change the materials during the procedure (angioplasty). [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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
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Responsible Party: Denise Oliveira, Principal Investigator, Assistent Cardiologist, Hospital Sao Lucas da PUCRS Identifier: NCT01632501    
Other Study ID Numbers: PCR1TS
First Posted: July 3, 2012    Key Record Dates
Last Update Posted: July 4, 2012
Last Verified: January 2011
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases