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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01097434
First received: March 31, 2010
Last updated: January 12, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Coronary Heart Disease
 Device: Biodegradable polymer limus-eluting stents
Device: Permanent polymer limus-eluting stent
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Percentage of uncovered stent strut segments assessed by OCT [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of malposed stent strut segments assessed by OCT [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: April 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097434

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

No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01097434     History of Changes
Other Study ID Numbers: GE IDE No. S03110
Study First Received: March 31, 2010
Last Updated: January 12, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 16, 2013