Test Safety of Biodegradable and Permanent Limus-Eluting Stents Assessed by Optical Coherence Tomography
TEST-6-OCT
Randomized Comparison of Limus-Eluting Stents With Biodegradable or Permanent Polymer Coating Regarding Stent Coverage Assessed by Optical Coherence Tomography
1 other identifier
interventional
48
1 country
1
Brief Summary
The objective of the study is to assess the superiority of the biodegradable polymer based limus-eluting stent (Nobori®) compared with the permanent polymer based everolimus-eluting stent (XIENCE V®) regarding absolute percentage of uncovered stent strut segments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2010
CompletedFirst Posted
Study publicly available on registry
April 1, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedJanuary 13, 2012
January 1, 2012
1.1 years
March 31, 2010
January 12, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of uncovered stent strut segments assessed by OCT
6-8 months
Secondary Outcomes (1)
Percentage of malposed stent strut segments assessed by OCT
6-8 months
Study Arms (2)
Arm 1
ACTIVE COMPARATORBiodegradable polymer limus-eluting stents
Arm 2
ACTIVE COMPARATORPermanent polymer limus-eluting stent
Interventions
due randomization biodegradable polymer limus-eluting stents will be implanted
due randomization permanent polymer limus-eluting stent will be implanted
Eligibility Criteria
You may qualify if:
- Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels
- Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
- In women with childbearing potential a negative pregnancy test is mandatory
You may not qualify if:
- Lesion length \>16mm requiring a stent length \>18mm
- Target lesion located in the left main trunk
- In-stent restenosis
- Acute myocardial infarction
- Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance
- Known allergy to the study medications: rapamycin, everolimus, biolimus, stainless steel or cobalt chrome
- Inability to take dual antiplatelet therapy for at least 6 months
- Pregnancy (present, suspected or planned) or positive pregnancy test
- Previous enrollment in this trial
- Patient's inability to fully cooperate with the study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Deutsches Herzzentrum Muenchen
Munich, 80636, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julinda Mehilli, MD
Deutsches Herzzentrum Muenchen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2010
First Posted
April 1, 2010
Study Start
April 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
January 13, 2012
Record last verified: 2012-01