Coronary DiseaseNCT00243438
DaVinci Registry(Distinctly Assess Vision in Coronary Intervention)
An observational study of Coronary Disease, run by Abbott Medical Devices at 1 site in Germany.
Trial summary
Prospective Internet-Registry, Postmarketing-Surveillance, Registration and Follow-up of patients after Multi-Link VISION™ - Stent Implantation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Multilink Vision™ Stent (CE-labeled)
- Type of treatment
- Medical device
- How many people
- 1,300 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2003to Mar 2005
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diabetes and/or complex coronary artery disease who are treated with a Multi-Link Vision™ Stent.
Who may be able to join
- Women and Men Age >18 years, Intention to treat all stenosis with Multi-Link VisionTM Stents, documented patient consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distinctly Access Vision In Coronary Interventions
Prospective Internet-Registry, Postmarketing-Surveillance, Registration and Follow-up of patients after Multi-Link VISION™ - Stent Implantation
Read the 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
- Conditions
- Coronary Disease
- Being tested
- Multilink Vision™ Stent (CE-labeled)
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multilink Vision™ Stent (CE-labeled)Device
Patients who have diabetes and/or complex lesions and who have had a Multilink Vision™ Stent placed.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients who have received a Vision stent and who have diabetes and/or complex lesions. Receives: Device: Multilink Vision™ Stent (CE-labeled) |
What is being measured
The primary outcome is the main question the study is designed to answer.
TVF
Measured: 9 months
Secondary outcomes (4)
Mode of death
Time to first MI
TVR
CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2005 (estimated)
- Study startJul 2003
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christian Hamm, MD, Principal investigator, Kerckhoff-Klinik/ Benekestr. 2-8/ 61231 Bad Nauheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243438
- Sponsor's protocol ID
- Version vom 18.7.2003
- Status last verified
- Jan 2009
- First submitted
- 21 Oct 2005
- Last updated
- 28 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes