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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
Bavaria
-
Munich, Bavaria, Tyskland, 81675
- Rekruttering
- Klinikum rechts der Isar
-
Ta kontakt med:
- Steffen Massberg, MD
- Telefonnummer: 4025 +49 89 12 18
- E-post: massberg@dhm.mhn.de
-
Munich, Bavaria, Tyskland, 80636
- Rekruttering
- Deutsches Herzzentrum Muenchen
-
Ta kontakt med:
- Julinda Mehilli, MD
- Telefonnummer: 4582 +49 89 12 18
- E-post: mehilli@dhm.mhn.de
-
Ta kontakt med:
- Klaus Tiroch, MD
- Telefonnummer: 4578 +49 89 12 18
- E-post: tiroch@dhm.mhn.de
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Arm 1
Sirolimus-Permanent-Polymer Eluting Stent
|
due randomization sirolimus-permanent-polymer eluting stent was implanted
Andre navn:
|
|
Aktiv komparator: Arm 2
Sirolimus-Polymer-free Eluting Stent
|
due randomization sirolimus-polymer-free eluting stent was implanted
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Degree of stent strut coverage after 5 years assessed by OCT for each visible strut segment
Tidsramme: 5 years
|
5 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage of malapposed strut assessed by OCT
Tidsramme: 5 years
|
5 years
|
|
Percentage of uncovered malapposed struts assessed by OCT
Tidsramme: 5 years
|
5 years
|
|
Morphologic differences of neointima between stents
Tidsramme: 5 years
|
5 years
|
|
Late lumen loss at 5 years assessed by OCT
Tidsramme: 5 years
|
5 years
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Klaus Tiroch, MD, Deutsches Herzzentrum Muenchen
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Arteriosklerose
- Arterielle okklusive sykdommer
- Hjertesykdommer
- Koronararteriesykdom
- Myokardiskemi
- Koronar sykdom
- Fysiologiske effekter av legemidler
- Anti-infeksjonsmidler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antibakterielle midler
- Antibiotika, antineoplastisk
- Antifungale midler
- Sirolimus
Andre studie-ID-numre
- GE IDE No. S03310
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