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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Denise Oliveira, Hospital Sao Lucas da PUCRS
ClinicalTrials.gov Identifier:
NCT01632501
First received: June 26, 2012
Last updated: July 2, 2012
Last verified: January 2011

June 26, 2012
July 2, 2012
January 2011
March 2012   (final data collection date for primary outcome measure)
Occurrence of: need to change the materials during the procedure (angioplasty). [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Occurrence of: need to change the materials during the procedure (angioplasty), occurrence of thrombosis, death or myocardial infarction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01632501 on ClinicalTrials.gov Archive Site
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Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand
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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Interventional
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Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Atherosclerotic Heart Disease
  • Coronary Heart Disease
Device: Coronary stent - Tsunami
A coronary angioplasty was done
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
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March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01632501
PCR1TS
Yes
Denise Oliveira, Hospital Sao Lucas da PUCRS
Hospital Sao Lucas da PUCRS
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Hospital Sao Lucas da PUCRS
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP