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Comparative Phase IV Study: Efficacy And Safety of TiTAN2 Versus COBALT-CHROME Stents- EVIDENCEII

NCT01918150 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1350

Last updated 2014-01-08

No results posted yet for this study

Summary

The purpose of this study is to compare the effectiveness and safety, at 24 months, of the TITAN2 stent to any bare-metal stent (BMS) in Cobalt-Chromium in a population presenting an indication for these stents among 40% of which present an acute coronary syndrome (ACS).

Conditions

  • Silent Myocardial Infarction
  • Stable Angina
  • Acute Coronary Syndrome

Interventions

DEVICE

Titan 2 stents

The intervention is called Percutaneous Coronary Intervention (PCI); Commonly known as coronary angioplasty or simply angioplasty, it is a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease. PCI is usually performed by an interventional cardiologist.

DEVICE

Cobalt-Chromium Bare Metal Stents

The intervention is called Percutaneous Coronary Intervention (PCI); Commonly known as coronary angioplasty or simply angioplasty, it is a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease. PCI is usually performed by an interventional cardiologist.

Sponsors & Collaborators

  • Hexacath, France

    lead INDUSTRY

Principal Investigators

  • Gilles RIOUFOL, Pr · Hospices Civils de Lyon- Bron - France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2015-12-31
Completion
2016-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01918150 on ClinicalTrials.gov