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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014