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

NCT01632501 | Completed DMC

• 1 other identifier: PCR1TS
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atherosclerotic Heart Disease; Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

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

  12 months

Interventions

Coronary stent - Tsunami DEVICE

A coronary angioplasty was done

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study included both male and female patients for stent implantation referred for angioplasty of coronary arteries with more than 18 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Sao Lucas da PUCRS: lead

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistent Cardiologist

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: July 3, 2012
• Study Start: January 1, 2011
• Primary Completion: March 1, 2012
• Last Updated: July 4, 2012

Record last verified: 2011-01