DaVinci Registry(Distinctly Assess Vision in Coronary Intervention)

January 27, 2009 updated by: Abbott Medical Devices

Distinctly Access Vision In Coronary Interventions

Prospective Internet-Registry, Postmarketing-Surveillance, Registration and Follow-up of patients after Multi-Link VISION™ - Stent Implantation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Non-Randomized prospective evaluation of the Multi-Link Rx Vision TM Coronary Stent System in the treatment of patients with De novo native coronary artery lesions

Study Type

Observational

Enrollment

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Nauheim, Germany, 61231
        • Kerckhoff-Klinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diabetes and/or complex coronary artery disease who are treated with a Multi-Link Vision™ Stent.

Description

Inclusion Criteria:

  • Women and Men Age >18 years, Intention to treat all stenosis with Multi-Link VisionTM Stents, documented patient consent

Exclusion Criteria:

  • No Multi-Link Vision™ Stent implanted, life expectation >9 M, cardiogenic shock, STEMI, NSTEMI or unstable angina pectoris with pathologic markers within the last 48 hours, intolerance of Clopidogrel/ Tiklopidin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Patients who have received a Vision stent and who have diabetes and/or complex lesions.
Device: Multilink Vision™ Stent (CE-labeled)
Patients who have diabetes and/or complex lesions and who have had a Multilink Vision™ Stent placed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TVF
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Mode of death
Time to first MI
TVR
CABG

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Christian Hamm, MD, Kerckhoff-Klinik/ Benekestr. 2-8/ 61231 Bad Nauheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

March 1, 2005

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

October 21, 2005

First Submitted That Met QC Criteria

October 21, 2005

First Posted (Estimate)

October 24, 2005

Study Record Updates

Last Update Posted (Estimate)

January 28, 2009

Last Update Submitted That Met QC Criteria

January 27, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version vom 18.7.2003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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3
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