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Test Safety of Biodegradable and Permanent Limus-Eluting Stents Assessed by Optical Coherence Tomography (TEST-6-OCT)

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ClinicalTrials.gov Identifier: NCT01097434
Recruitment Status : Completed
First Posted : April 1, 2010
Last Update Posted : January 13, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Device: Biodegradable polymer limus-eluting stents Device: Permanent polymer limus-eluting stent Phase 4

Detailed Description:
The mid-term efficacy of drug-eluting stents has been well-established, but there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with permanent polymer-based DES. The extent of strut coverage with reduction of exposed thrombogenic material has been shown to be associated with the inflammatory reaction grade and with the incidence of stent thrombosis. The optical coherence tomography (OCT) is an intravascular imaging modality based on light. The principle is similar to intravascular ultrasound, but due to the much shorter wave length of light, it offers a much better resolution up to 10µm, enabling the exact determination of strut coverage, neointimal thickness, vessel size, presence of dissections, and even the presence of inflammation.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Limus-Eluting Stents With Biodegradable or Permanent Polymer Coating Regarding Stent Coverage Assessed by Optical Coherence Tomography
Study Start Date : April 2010
Primary Completion Date : May 2011
Study Completion Date : May 2011
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Arm 1
Biodegradable polymer limus-eluting stents
Device: Biodegradable polymer limus-eluting stents
due randomization biodegradable polymer limus-eluting stents will be implanted
Other Name: Nobori®
Active Comparator: Arm 2
Permanent polymer limus-eluting stent
Device: Permanent polymer limus-eluting stent
due randomization permanent polymer limus-eluting stent will be implanted
Other Name: Xience-V®

Outcome Measures

Primary Outcome Measures :
  1. Percentage of uncovered stent strut segments assessed by OCT [ Time Frame: 6-8 months ]

Secondary Outcome Measures :
  1. Percentage of malposed stent strut segments assessed by OCT [ Time Frame: 6-8 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097434

Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Principal Investigator: Julinda Mehilli, MD Deutsches Herzzentrum Muenchen
More Information

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01097434     History of Changes
Other Study ID Numbers: GE IDE No. S03110
First Posted: April 1, 2010    Key Record Dates
Last Update Posted: January 13, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases