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

History of Changes

Tracking Information
First Received Date ^ICMJE	June 26, 2012
Last Updated Date	July 2, 2012
Start Date ^ICMJE	January 2011
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 2, 2012)	Occurrence of: need to change the materials during the procedure (angioplasty). [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: June 28, 2012)	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 ]
Change History	Complete list of historical versions of study NCT01632501 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand
Official Title ^ICMJE	Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Atherosclerotic Heart Disease Coronary Heart Disease
Intervention ^ICMJE	Device: Coronary stent - Tsunami A coronary angioplasty was done
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	84
Completion Date	Not Provided
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01632501
Other Study ID Numbers ^ICMJE	PCR1TS
Has Data Monitoring Committee	Yes
Responsible Party	Denise Oliveira, Hospital Sao Lucas da PUCRS
Study Sponsor ^ICMJE	Hospital Sao Lucas da PUCRS
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hospital Sao Lucas da PUCRS
Verification Date	January 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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