Status:
UNKNOWN
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
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
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 discontin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01260558
Start Date
December 1 2010
End Date
December 1 2012
Last Update
May 8 2012
Active Locations (2)
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1
Deutsches Herzzentrum Muenchen
Munich, Bavaria, Germany, 80636
2
Klinikum rechts der Isar
Munich, Bavaria, Germany, 81675