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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

March 31, 2010
January 12, 2012
April 2010
May 2011   (final data collection date for primary outcome measure)
Percentage of uncovered stent strut segments assessed by OCT [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]
Percentage of uncovered stent strut segments assessed by OCT for each evaluable strut segment [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01097434 on ClinicalTrials.gov Archive Site
Percentage of malposed stent strut segments assessed by OCT [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]
  • Percentage of malapposed stent strut segments assessed by OCT for each evaluable strut segment [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]
  • Percentage of uncovered malapposed stent strut segments assessed by OCT for each evaluable strut segment [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Test Safety of Biodegradable and Permanent Limus-Eluting Stents Assessed by Optical Coherence Tomography
Randomized Comparison of Limus-Eluting Stents With Biodegradable or Permanent Polymer Coating Regarding Stent Coverage Assessed by Optical Coherence Tomography

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Heart Disease
  • Device: Biodegradable polymer limus-eluting stents
    due randomization biodegradable polymer limus-eluting stents will be implanted
    Other Name: Nobori®
  • Device: Permanent polymer limus-eluting stent
    due randomization permanent polymer limus-eluting stent will be implanted
    Other Name: Xience-V®
  • Active Comparator: Arm 1
    Biodegradable polymer limus-eluting stents
    Intervention: Device: Biodegradable polymer limus-eluting stents
  • Active Comparator: Arm 2
    Permanent polymer limus-eluting stent
    Intervention: Device: Permanent polymer limus-eluting stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01097434
GE IDE No. S03110
No
Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
Not Provided
Principal Investigator: Julinda Mehilli, MD Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP