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OpenTrials
Completed

NCT Number: NCT01632501

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary stent - Tsunami

Device

A coronary angioplasty was done

Primary outcomes

  1. Occurrence of: need to change the materials during the procedure (angioplasty).

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hospital Sao Lucas da PUCRS

Other

Registry information

Acronym: Tsunami

Important dates

Study start
2011
Primary completion
2012
First posted
Jul 3, 2012
Registry last updated
Jul 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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