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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
  Purpose

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 Intervention
Atherosclerotic Heart Disease
Coronary Heart Disease
 Device: Coronary stent - Tsunami

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Sao Lucas da PUCRS:

Primary Outcome Measures:
  • Occurrence of: need to change the materials during the procedure (angioplasty). [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 84
Study Start Date: January 2011
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Coronary stent - Tsunami
    A coronary angioplasty was done
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Denise Oliveira, Principal Investigator, Assistent Cardiologist, Hospital Sao Lucas da PUCRS
ClinicalTrials.gov Identifier: NCT01632501     History of Changes
Other Study ID Numbers: PCR1TS
Study First Received: June 26, 2012
Last Updated: July 2, 2012
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013