Clinical trial NCT01260558: 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: Pilop Trial of OCT-determined Coverage of Permanent or Polymer-free Sirolimus Eluting Stent at Long Term
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Heart Disease
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2010-12-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Degree of stent strut coverage after 5 years assessed by OCT for each visible strut segment
timeFrame: 5 years
Secondary outcomes:
measure: Percentage of malapposed strut assessed by OCT
timeFrame: 5 years
measure: Percentage of uncovered malapposed struts assessed by OCT
timeFrame: 5 years
measure: Morphologic differences of neointima between stents
timeFrame: 5 years
measure: Late lumen loss at 5 years assessed by OCT
timeFrame: 5 years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
state: Bavaria
city: Munich
country: Germany
facility: Klinikum rechts der Isar
state: Bavaria
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Klaus Tiroch, MD
role: PRINCIPAL_INVESTIGATOR
References: