DaVinci Registry(Distinctly Assess Vision in Coronary Intervention)

Completed

• Conditions: Coronary Disease

• Registration Number: NCT00243438
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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

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 Timeline

• Study Start: 2003-07
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Study First Submitted: 2005-10-21
• Study First Submitted QC: 2005-10-21
• Study First Posted: 2005-10-24
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-27
• Last Update Posted: 2009-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TVF	9 months

Secondary Outcome Measures

Name	Time	Method
Mode of death
Time to first MI
TVR
CABG

Trial Locations

Locations (1)

Kerckhoff-Klinik; 🇩🇪 Bad Nauheim, Germany