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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distinctly Access Vision In Coronary Interventions
- ClinicalTrials.gov ID
- NCT00243438
- Acronym / sponsor ID
- Version vom 18.7.2003
- Conditions
- Coronary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,300 participants
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 24 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective Internet-Registry, Postmarketing-Surveillance, Registration and Follow-up of patients after Multi-Link VISION™ - Stent Implantation
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Multilink Vision™ Stent (CE-labeled)Patients who have received a Vision stent and who have diabetes and/or complex lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetes and/or complex coronary artery disease who are treated with a Multi-Link Vision™ Stent.
Key inclusion criteria (1 listed)
- Women and Men Age >18 years, Intention to treat all stenosis with Multi-Link VisionTM Stents, documented patient consent
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multilink Vision™ Stent (CE-labeled)Patients who have diabetes and/or complex lesions and who have had a Multilink Vision™ Stent placed. | Device | 1 |
Primary outcome
TVF
Time frame: 9 months
4 secondary outcomes
Mode of death
Time to first MI
TVR
CABG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Hamm, MD principal investigator
Kerckhoff-Klinik/ Benekestr. 2-8/ 61231 Bad Nauheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by Abbott Medical Devices at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TVF (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2009.