DaVinci Registry(Distinctly Assess Vision in Coronary Intervention)

NCT ID: NCT00243438

Last Updated: 2009-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-07-31

Study Completion Date

2005-03-31

Brief Summary

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

Detailed Description

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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

Conditions

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Coronary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients who have received a Vision stent and who have diabetes and/or complex lesions.

Multilink Vision™ Stent (CE-labeled)

Intervention Type DEVICE

Patients who have diabetes and/or complex lesions and who have had a Multilink Vision™ Stent placed.

Interventions

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Multilink Vision™ Stent (CE-labeled)

Patients who have diabetes and/or complex lesions and who have had a Multilink Vision™ Stent placed.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott Vascular

Principal Investigators

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Christian Hamm, MD

Role: PRINCIPAL_INVESTIGATOR

Kerckhoff-Klinik/ Benekestr. 2-8/ 61231 Bad Nauheim

Locations

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Kerckhoff-Klinik

Bad Nauheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Version vom 18.7.2003

Identifier Type: -

Identifier Source: org_study_id

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