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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 recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Deutsches Herzzentrum Muenchen.
Recruitment status was  Recruiting
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
  Purpose

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 Intervention Phase
Coronary Heart Disease
Device: Sirolimus-Permanent-Polymer Eluting Stent
Device: Sirolimus-Polymer-free Eluting Stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilop Trial of OCT-determined Coverage of Permanent or Polymer-free Sirolimus Eluting Stent at Long Term

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: December 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260558

Contacts
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

Locations
Germany
Deutsches Herzzentrum Muenchen Recruiting
Munich, Bavaria, Germany, 80636
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   
Klinikum rechts der Isar Recruiting
Munich, Bavaria, Germany, 81675
Contact: Steffen Massberg, MD    +49 89 12 18 ext 4025    massberg@dhm.mhn.de   
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Principal Investigator: Klaus Tiroch, MD Deutsches Herzzentrum Muenchen
  More Information

No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01260558     History of Changes
Other Study ID Numbers: GE IDE No. S03310
Study First Received: December 14, 2010
Last Updated: May 7, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Vascular Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014