DaVinci Registry(Distinctly Assess Vision in Coronary Intervention)

Coronary Disease Clinical Trial

Official title:

Distinctly Access Vision In Coronary Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243438
• Other study ID #: Version vom 18.7.2003
• Status: Completed
• Phase: Phase 4
• First received: October 21, 2005
• Last updated: January 27, 2009
• Start date: July 2003
• Est. completion date: March 2005

Study information

• Verified date: January 2009
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• Multilink Vision™ Stent (CE-labeled)
Patients who have diabetes and/or complex lesions and who have had a Multilink Vision™ Stent placed.

Locations

Country	Name	City	State
Germany	Kerckhoff-Klinik	Bad Nauheim

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TVF		9 months	Yes
Secondary	Mode of death			Yes
Secondary	Time to first MI			Yes
Secondary	TVR			Yes
Secondary	CABG			Yes