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
Pilop Trial of OCT-determined Coverage of Permanent or Polymer-free Sirolimus Eluting Stent at Long Term
1 other identifier
interventional
20
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 14, 2010
CompletedFirst Posted
Study publicly available on registry
December 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMay 8, 2012
May 1, 2012
2 years
December 14, 2010
May 7, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Degree of stent strut coverage after 5 years assessed by OCT for each visible strut segment
5 years
Secondary Outcomes (4)
Percentage of malapposed strut assessed by OCT
5 years
Percentage of uncovered malapposed struts assessed by OCT
5 years
Morphologic differences of neointima between stents
5 years
Late lumen loss at 5 years assessed by OCT
5 years
Study Arms (2)
Arm 1
ACTIVE COMPARATORSirolimus-Permanent-Polymer Eluting Stent
Arm 2
ACTIVE COMPARATORSirolimus-Polymer-free Eluting Stent
Interventions
due randomization sirolimus-permanent-polymer eluting stent was implanted
due randomization sirolimus-polymer-free eluting stent was implanted
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Deutsches Herzzentrum Muenchen
Munich, Bavaria, 80636, Germany
Klinikum rechts der Isar
Munich, Bavaria, 81675, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Klaus Tiroch, MD
Deutsches Herzzentrum Muenchen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2010
First Posted
December 15, 2010
Study Start
December 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
May 8, 2012
Record last verified: 2012-05