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

Coronary Heart Disease Clinical Trial

— PPS/PFS-OCT  

Official title:

Pilop Trial of OCT-determined Coverage of Permanent or Polymer-free Sirolimus Eluting Stent at Long Term

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01260558
• Other study ID #: GE IDE No. S03310
• Status: Recruiting
• Phase: Phase 4
• First received: December 14, 2010
• Last updated: May 7, 2012
• Start date: December 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2012
• Source: Deutsches Herzzentrum Muenchen
• Contact: Julinda Mehilli, MD
• Phone: +49 89 12 18
• Email: mehilli[@]dhm.mhn.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia

Intervention

Device:
• Sirolimus-Permanent-Polymer Eluting Stent
due randomization sirolimus-permanent-polymer eluting stent was implanted
• Sirolimus-Polymer-free Eluting Stent
due randomization sirolimus-polymer-free eluting stent was implanted

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Muenchen	Munich	Bavaria
Germany	Klinikum rechts der Isar	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of stent strut coverage after 5 years assessed by OCT for each visible strut segment		5 years	Yes
Secondary	Percentage of malapposed strut assessed by OCT		5 years	Yes
Secondary	Percentage of uncovered malapposed struts assessed by OCT		5 years	Yes
Secondary	Morphologic differences of neointima between stents		5 years	Yes
Secondary	Late lumen loss at 5 years assessed by OCT		5 years	No