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
NCT01260558 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2012-05-08
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.
Conditions
Interventions
- DEVICE
-
Sirolimus-Permanent-Polymer Eluting Stent
due randomization sirolimus-permanent-polymer eluting stent was implanted
- DEVICE
-
Sirolimus-Polymer-free Eluting Stent
due randomization sirolimus-polymer-free eluting stent was implanted
Sponsors & Collaborators
-
Deutsches Herzzentrum Muenchen
lead OTHER
Principal Investigators
-
Klaus Tiroch, MD · Deutsches Herzzentrum Muenchen
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-12-31
- Primary Completion
- 2012-12-31
- Completion
- 2012-12-31
Countries
- Germany
Study Locations
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