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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Device: Sirolimus-Permanent-Polymer Eluting Stent Device: Sirolimus-Polymer-free Eluting Stent Phase 4

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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilop Trial of OCT-determined Coverage of Permanent or Polymer-free Sirolimus Eluting Stent at Long Term
Study Start Date : December 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
Active Comparator: Arm 1
Sirolimus-Permanent-Polymer Eluting Stent
Device: Sirolimus-Permanent-Polymer Eluting Stent
due randomization sirolimus-permanent-polymer eluting stent was implanted
Other Name: Cypher®

Active Comparator: Arm 2
Sirolimus-Polymer-free Eluting Stent
Device: Sirolimus-Polymer-free Eluting Stent
due randomization sirolimus-polymer-free eluting stent was implanted
Other Name: ISAR Rapa G1

Primary Outcome Measures :
  1. Degree of stent strut coverage after 5 years assessed by OCT for each visible strut segment [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Percentage of malapposed strut assessed by OCT [ Time Frame: 5 years ]
  2. Percentage of uncovered malapposed struts assessed by OCT [ Time Frame: 5 years ]
  3. Morphologic differences of neointima between stents [ Time Frame: 5 years ]
  4. Late lumen loss at 5 years assessed by OCT [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01260558

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Contact: Julinda Mehilli, MD +49 89 12 18 ext 4582
Contact: Klaus Tiroch, MD +49 89 12 18 ext 4578

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Deutsches Herzzentrum Muenchen Recruiting
Munich, Bavaria, Germany, 80636
Contact: Julinda Mehilli, MD    +49 89 12 18 ext 4582   
Contact: Klaus Tiroch, MD    +49 89 12 18 ext 4578   
Klinikum rechts der Isar Recruiting
Munich, Bavaria, Germany, 81675
Contact: Steffen Massberg, MD    +49 89 12 18 ext 4025   
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
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Principal Investigator: Klaus Tiroch, MD Deutsches Herzzentrum Muenchen

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Responsible Party: Deutsches Herzzentrum Muenchen Identifier: NCT01260558     History of Changes
Other Study ID Numbers: GE IDE No. S03310
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs