NCT00368953

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2006

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 2, 2010

Status Verified

January 1, 2010

Enrollment Period

3.3 years

First QC Date

August 28, 2006

Last Update Submit

February 1, 2010

Conditions

Coronary Arteriosclerosis

Outcome Measures

Primary Outcomes (1)

  • "In-stent late lumen loss" at follow-up-angiography (9 months)

    9 months

Secondary Outcomes (8)

  • Binary restenosis

    9 months

  • Target vessel revascularisation rate

    9 months

  • Target lesion revascularisation rate

    9 months

  • Late loss (in-segment)

    9 months

  • MLD und diameter of stenosis (%)

    9 months

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Device: Yukon Choice stent system

2

ACTIVE COMPARATOR
Device: Taxus Liberté stent system

Interventions

Yukon Choice stent systemDEVICE

coronary stent implantation

1
Taxus Liberté stent systemDEVICE

coronary stent implantation

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leipzig Heart Center

Leipzig, 04289, Germany

Location

Related Publications (2)

  • 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.

    PMID: 23873579DERIVED

  • Desch 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.

    PMID: 21511226DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Holger Thiele, MD

    Heart Center Leipzig - University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2006

First Posted

August 29, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 2, 2010

Record last verified: 2010-01

Locations

DE(1)