Test of Long-Term Safety and Efficacy of Sirolimus-Permanent-Polymer Eluting Stent (Cypher)- and Sirolimus-Polymer-free Eluting Stents (PPS/PFS) Assessed by Optical Coherence Tomography (PPS/PFS-OCT)

This study is currently recruiting participants.
Verified May 2012 by Deutsches Herzzentrum Muenchen
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01260558
First received: December 14, 2010
Last updated: May 7, 2012
Last verified: May 2012

December 14, 2010
May 7, 2012
December 2010
December 2012   (final data collection date for primary outcome measure)
Degree of stent strut coverage after 5 years assessed by OCT for each visible strut segment [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01260558 on ClinicalTrials.gov Archive Site
  • Percentage of malapposed strut assessed by OCT [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Percentage of uncovered malapposed struts assessed by OCT [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Morphologic differences of neointima between stents [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Late lumen loss at 5 years assessed by OCT [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Test of Long-Term Safety and Efficacy of Sirolimus-Permanent-Polymer Eluting Stent (Cypher)- and Sirolimus-Polymer-free Eluting Stents (PPS/PFS) Assessed by Optical Coherence Tomography
Pilop Trial of OCT-determined Coverage of Permanent or Polymer-free Sirolimus Eluting Stent at Long Term

The objective of this pilot study is to compare the PFS-eluting stent (ISAR Rapa G1) with the PPS-eluting stent (Cypher®) regarding uncovered stent strut segments at 5 years.

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.

Patients who received a polymer-free or a permanent-polymer sirolimus-eluting stent about 5 years ago without in-segment intervention since, will be evaluated by OCT regarding the healing pattern and the late lumen loss of the stent.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Heart Disease
  • Device: Sirolimus-Permanent-Polymer Eluting Stent
    due randomization sirolimus-permanent-polymer eluting stent was implanted
    Other Name: Cypher®
  • Device: Sirolimus-Polymer-free Eluting Stent
    due randomization sirolimus-polymer-free eluting stent was implanted
    Other Name: ISAR Rapa G1
  • Active Comparator: Arm 1
    Sirolimus-Permanent-Polymer Eluting Stent
    Intervention: Device: Sirolimus-Permanent-Polymer Eluting Stent
  • Active Comparator: Arm 2
    Sirolimus-Polymer-free Eluting Stent
    Intervention: Device: Sirolimus-Polymer-free Eluting Stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients older than age 18 with with previous implantation of polymer-free or permanent-polymer sirolimus-eluting stents 5 years ago due to 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 and assessment by OCT.
  • In women with childbearing potential a negative pregnancy test is mandatory.

Exclusion Criteria:

  • Intervention in the segment of the study stent after the index procedure
  • Target lesion located in the left main trunk.
  • In-stent restenosis with difficulty to pass the OCT device
  • Acute myocardial infarction
  • Known allergy to the study medications: Sirolimus, rapamycin, probucol or stainless steel.
  • Pregnancy (present, suspected or planned) or positive pregnancy test.
  • Patient's inability to fully cooperate with the study protocol.
Both
18 Years and older
No
Contact: Julinda Mehilli, MD +49 89 12 18 ext 4582 mehilli@dhm.mhn.de
Contact: Klaus Tiroch, MD +49 89 12 18 ext 4578 tiroch@dhm.mhn.de
Germany
 
NCT01260558
GE IDE No. S03310
No
Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
Not Provided
Principal Investigator: Klaus Tiroch, MD Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
May 2012

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