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)

Tracking Information
First Submitted Date ICMJE	December 14, 2010
First Posted Date ICMJE	December 15, 2010
Last Update Posted Date	May 8, 2012
Study Start Date ICMJE	December 2010
Estimated Primary Completion Date	December 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 14, 2010)	Degree of stent strut coverage after 5 years assessed by OCT for each visible strut segment [ Time Frame: 5 years ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01260558 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 14, 2010)	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 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	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
Official Title ICMJE	Pilop Trial of OCT-determined Coverage of Permanent or Polymer-free Sirolimus Eluting Stent at Long Term
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 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.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Coronary Heart Disease
Intervention ICMJE	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
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: December 14, 2010)	20
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	December 2012
Estimated Primary Completion Date	December 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Germany
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01260558
Other Study ID Numbers ICMJE	GE IDE No. S03310
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Deutsches Herzzentrum Muenchen
Study Sponsor ICMJE	Deutsches Herzzentrum Muenchen
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Klaus Tiroch, MD Deutsches Herzzentrum Muenchen
PRS Account	Deutsches Herzzentrum Muenchen
Verification Date	May 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP