A Phase 4 interventional study of Sirolimus-Permanent-Polymer Eluting Stent and Sirolimus-Polymer-free Eluting Stent in Coronary Heart Disease, sponsored by Deutsches Herzzentrum Muenchen. Status unknown at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-08.
Sponsored by Deutsches Herzzentrum Muenchen · Phase 4, Interventional, and Treatment
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.
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.
3,640 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 20 is below the median of 100 across 1,779 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Deutsches Herzzentrum Muenchen is the lead sponsor of 112 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Sirolimus-Permanent-Polymer Eluting Stent
Device: Sirolimus-Permanent-Polymer Eluting Stent
Sirolimus-Polymer-free Eluting Stent
Device: Sirolimus-Polymer-free Eluting Stent
due randomization sirolimus-permanent-polymer eluting stent was implanted
Also known as: Cypher®
due randomization sirolimus-polymer-free eluting stent was implanted
Also known as: ISAR Rapa G1
Degree of stent strut coverage after 5 years assessed by OCT for each visible strut segment
Time frame: 5 years
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
This study is status unknown, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Deutsches Herzzentrum Muenchen