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DaVinci Registry(Distinctly Assess Vision in Coronary Intervention)

This study has been completed.
Sponsor:
Information provided by:
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00243438
First received: October 21, 2005
Last updated: January 27, 2009
Last verified: January 2009
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

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

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

ClinicalTrials.gov processed this record on May 16, 2013