DaVinci Registry(Distinctly Assess Vision in Coronary Intervention) - Full Text View

Sponsored by:	Abbott Vascular
Information provided by:	Abbott Vascular
ClinicalTrials.gov Identifier:	NCT00243438

Purpose

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

Condition	Intervention	Phase
Coronary Disease	Device: Multilink Vision™ Stent (CE-labeled)	Phase IV

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Distinctly Access Vision In Coronary Interventions

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:

TVF [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mode of death [ Designated as safety issue: Yes ]
Time to first MI [ Designated as safety issue: Yes ]
TVR [ Designated as safety issue: Yes ]
CABG [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1300
Study Start Date:	July 2003
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243438

Locations

Germany
Kerckhoff-Klinik
Bad Nauheim, Germany, 61231

Sponsors and Collaborators

Abbott Vascular

Investigators

Principal Investigator:

Christian Hamm, MD

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

More Information

No publications provided

Responsible Party:	Abbott Vascular ( Matt Kiely )
Study ID Numbers:	Version vom 18.7.2003
Study First Received:	October 21, 2005
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00243438 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009