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DaVinci Registry(Distinctly Assess Vision in Coronary Intervention)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00243438
First Posted: October 24, 2005
Last Update Posted: January 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott Vascular
  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 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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 ]

Secondary Outcome Measures:
  • Mode of death
  • Time to first MI
  • TVR
  • CABG

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Matt Kiely, Abbott Vascular
ClinicalTrials.gov Identifier: NCT00243438     History of Changes
Other Study ID Numbers: Version vom 18.7.2003
First Submitted: October 21, 2005
First Posted: October 24, 2005
Last Update Posted: January 28, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases