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

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Biodegradable polymer limus-eluting stents
Permanent polymer limus-eluting stent
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Deutsches Herzzentrum Muenchen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Biodegradable polymer limus-eluting stents

Permanent polymer limus-eluting stent

Outcomes

Primary Outcome Measures

Percentage of uncovered stent strut segments assessed by OCT

Secondary Outcome Measures

Percentage of malposed stent strut segments assessed by OCT

Full Information

First Posted
March 31, 2010
Last Updated
January 12, 2012
Sponsor
Deutsches Herzzentrum Muenchen
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1. Study Identification

Unique Protocol Identification Number
NCT01097434
Brief Title
Test Safety of Biodegradable and Permanent Limus-Eluting Stents Assessed by Optical Coherence Tomography
Acronym
TEST-6-OCT
Official Title
Randomized Comparison of Limus-Eluting Stents With Biodegradable or Permanent Polymer Coating Regarding Stent Coverage Assessed by Optical Coherence Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Biodegradable polymer limus-eluting stents
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Permanent polymer limus-eluting stent
Intervention Type
Device
Intervention Name(s)
Biodegradable polymer limus-eluting stents
Other Intervention Name(s)
Nobori®
Intervention Description
due randomization biodegradable polymer limus-eluting stents will be implanted
Intervention Type
Device
Intervention Name(s)
Permanent polymer limus-eluting stent
Other Intervention Name(s)
Xience-V®
Intervention Description
due randomization permanent polymer limus-eluting stent will be implanted
Primary Outcome Measure Information:
Title
Percentage of uncovered stent strut segments assessed by OCT
Time Frame
6-8 months
Secondary Outcome Measure Information:
Title
Percentage of malposed stent strut segments assessed by OCT
Time Frame
6-8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julinda Mehilli, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
ZIP/Postal Code
80636
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Test Safety of Biodegradable and Permanent Limus-Eluting Stents Assessed by Optical Coherence Tomography

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