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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01260558
Recruitment Status : Unknown
Verified May 2012 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Recruiting
First Posted : December 15, 2010
Last Update Posted : May 8, 2012
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

December 14, 2010
December 15, 2010
May 8, 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 ]
Same as current
Complete list of historical versions of study NCT01260558 on Archive Site
  • Percentage of malapposed strut assessed by OCT [ Time Frame: 5 years ]
  • Percentage of uncovered malapposed struts assessed by OCT [ Time Frame: 5 years ]
  • Morphologic differences of neointima between stents [ Time Frame: 5 years ]
  • Late lumen loss at 5 years assessed by OCT [ Time Frame: 5 years ]
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.

Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Identifier (NCT Number) in Medline.
Unknown status
Same as current
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
GE IDE No. S03310
Not Provided
Not Provided
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