Coronary ArteriosclerosisPhase 4NCT00368953
YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus
A Phase 4 study testing Yukon Choice stent system and Taxus Liberté stent system in people with Coronary Arteriosclerosis, run by University of Leipzig at 1 site in Germany.
Trial summary
Revascularisation procedures such as percutaneous coronary intervention are associated with overall worse outcomes in patients with diabetes mellitus. Implantation of coronary stents is associated with higher restenosis rates compared to non-diabetic individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arteriosclerosis
- What is being tested?
- Yukon Choice stent system and Taxus Liberté stent system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2006to Dec 2009
- Phase
- Phase 4
- 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
Who may be able to join
- age > 18 years
- diabetes mellitus
- symptoms (stable or unstable angina pectoris) or objective evidence of myocardial ischemia
- one or more de novo lesions in 1, 2 or 3 native coronary arteries
- clinically significant diameter of stenosis (50-99 % according to visual assessment of operator)
- lesion must be covered by stent length of no more than 24 mm and stent diameter of no more than 3,5 mm
- vessel diameter of no more than 4 mm in vessel area adjacent to stenosis
- informed consent
Who cannot join
- unprotected left main disease
- complete occlusion of target vessel
- in-stent-restenosis
- stenoses of bypass grafts
- indication for bypass surgery
- bifurcation lesions (side branch > 2,0 mm)
Show all 12Show fewer
- thrombus in target lesion as visualized by angiography
- allergy or contraindication to concomitant medication (clopidogrel, aspirin, heparin, contrast media)
- acute myocardial infarction within preceding 48h
- participation in another trial
- pregnancy
- severe disorder of coagulation or platelet function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Multicenter Comparison of the Drug-Eluting Stent Systems YUKON Choice and TAXUS Liberté in Patients With Diabetes Mellitus
Revascularisation procedures such as percutaneous coronary intervention are associated with overall worse outcomes in patients with diabetes mellitus. Implantation of coronary stents is associated with higher restenosis rates compared to non-diabetic individuals.
There is only limited data available on the efficacy and safety of the novel Yukon Choice drug-eluting stent system specifically in patients with diabetes mellitus. The trial will determine the efficacy and safety of the novel Yukon Choice stent system compared to the well established Taxus Liberté stent system. The primary endpoint will be "in-stent late lumen loss" at 9 months as determined by invasive angiography.
- Conditions
- Coronary Arteriosclerosis
- Being tested
- Yukon Choice stent system, Taxus Liberté stent system
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yukon Choice stent systemDevice
coronary stent implantation
Taxus Liberté stent systemDevice
coronary stent implantation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Yukon Choice stent system |
| 2 | Active comparator | Not described Receives: Device: Taxus Liberté stent system |
What is being measured
The primary outcome is the main question the study is designed to answer.
"In-stent late lumen loss" at follow-up-angiography (9 months)
Measured: 9 months
Secondary outcomes (8)
Binary restenosis
Measured: 9 months
Target vessel revascularisation rate
Measured: 9 months
Target lesion revascularisation rate
Measured: 9 months
Late loss (in-segment)
Measured: 9 months
MLD und diameter of stenosis (%)
Measured: 9 months
Death
Measured: 9 months
Success rate index procedure (residual diameter stenosis < 30%)
Measured: 0 months
Combined MACE (cardiac death, myocardial infarction, emergency bypass, stent thrombosis, target lesion revascularization)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Translumina GmbH
- Investigators
- Holger Thiele, MD, Principal investigator, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368953
- Sponsor's protocol ID
- Lipsia-Yukon-DM
- Status last verified
- Jan 2010
- First submitted
- 28 Aug 2006
- Last updated
- 2 Feb 2010
- Results posted
- No
Publications
Stiermaier T, Heinz A, Schloma D, Kleinertz K, Danschel W, Erbs S, Linke A, Boudriot E, Lauer B, Schuler G, Thiele H, Desch S. Five-year clinical follow-up of a randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus (LIPSIA Yukon trial). Catheter Cardiovasc Interv. 2014 Feb 15;83(3):418-24. doi: 10.1002/ccd.25131. Epub 2013 Aug 9.
PubMed 23873579Desch S, Schloma D, Mobius-Winkler S, Erbs S, Gielen S, Linke A, Yu J, Lauer B, Kleinertz K, Danschel W, Schuler G, Thiele H. Randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus: the LIPSIA Yukon trial. JACC Cardiovasc Interv. 2011 Apr;4(4):452-9. doi: 10.1016/j.jcin.2010.11.016.
PubMed 21511226
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter Comparison of the Drug-Eluting Stent Systems YUKON Choice and TAXUS Liberté in Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00368953
- Acronym / sponsor ID
- Lipsia-Yukon-DM
- Conditions
- Coronary Arteriosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Translumina GmbH
- Study start
- Sep 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Aug 2006 (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.
Revascularisation procedures such as percutaneous coronary intervention are associated with overall worse outcomes in patients with diabetes mellitus. Implantation of coronary stents is associated with higher restenosis rates compared to non-diabetic individuals.
There is only limited data available on the efficacy and safety of the novel Yukon Choice drug-eluting stent system specifically in patients with diabetes mellitus. The trial will determine the efficacy and safety of the novel Yukon Choice stent system compared to the well established Taxus Liberté stent system. The primary endpoint will be "in-stent late lumen loss" at 9 months as determined by invasive angiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Yukon Choice stent system |
| 2 | Active comparator | Device: Taxus Liberté stent system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age > 18 years
- diabetes mellitus
- symptoms (stable or unstable angina pectoris) or objective evidence of myocardial ischemia
- one or more de novo lesions in 1, 2 or 3 native coronary arteries
- clinically significant diameter of stenosis (50-99 % according to visual assessment of operator)
Key exclusion criteria (12 listed)
- unprotected left main disease
- complete occlusion of target vessel
- in-stent-restenosis
- stenoses of bypass grafts
- indication for bypass surgery
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 |
|---|---|---|
| Yukon Choice stent systemcoronary stent implantation | Device | 1 |
| Taxus Liberté stent systemcoronary stent implantation | Device | 2 |
Primary outcome
"In-stent late lumen loss" at follow-up-angiography (9 months)
Time frame: 9 months
8 secondary outcomes
Binary restenosis
Time frame: 9 months
Target vessel revascularisation rate
Time frame: 9 months
Target lesion revascularisation rate
Time frame: 9 months
Late loss (in-segment)
Time frame: 9 months
MLD und diameter of stenosis (%)
Time frame: 9 months
Death
Time frame: 9 months
Success rate index procedure (residual diameter stenosis < 30%)
Time frame: 0 months
Combined MACE (cardiac death, myocardial infarction, emergency bypass, stent thrombosis, target lesion revascularization)
Time frame: 9 months
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 2 Feb 2010.
- Derived from this study: PubMed 23873579Stiermaier T, Heinz A, Schloma D, Kleinertz K, Danschel W, Erbs S, Linke A, Boudriot E, Lauer B, Schuler G, Thiele H, Desch S. Five-year clinical follow-up of a randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus (LIPSIA Yukon trial). Catheter Cardiovasc Interv. 2014 Feb 15;83(3):418-24. doi: 10.1002/ccd.25131. Epub 2013 Aug 9.
- Derived from this study: PubMed 21511226Desch S, Schloma D, Mobius-Winkler S, Erbs S, Gielen S, Linke A, Yu J, Lauer B, Kleinertz K, Danschel W, Schuler G, Thiele H. Randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus: the LIPSIA Yukon trial. JACC Cardiovasc Interv. 2011 Apr;4(4):452-9. doi: 10.1016/j.jcin.2010.11.016.
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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.
Holger Thiele, MD principal investigator
Heart Center Leipzig - University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Yukon Choice stent system and Taxus Liberté stent system in people with Coronary Arteriosclerosis, run by University of Leipzig 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 8 inclusion and 12 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 2 Feb 2010. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
"In-stent late lumen loss" at follow-up-angiography (9 months) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00368953, which also lists 2 linked publications.
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 2 Feb 2010.