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

NCT ID: NCT01260558

Last Updated: 2012-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-12-31

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.

Detailed 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.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Sirolimus-Permanent-Polymer Eluting Stent

Group Type: ACTIVE_COMPARATOR

Sirolimus-Permanent-Polymer Eluting Stent

Intervention Type: DEVICE

due randomization sirolimus-permanent-polymer eluting stent was implanted

Arm 2

Sirolimus-Polymer-free Eluting Stent

Group Type: ACTIVE_COMPARATOR

Sirolimus-Polymer-free Eluting Stent

Intervention Type: DEVICE

due randomization sirolimus-polymer-free eluting stent was implanted

Interventions

Sirolimus-Permanent-Polymer Eluting Stent

due randomization sirolimus-permanent-polymer eluting stent was implanted

Intervention Type: DEVICE

Sirolimus-Polymer-free Eluting Stent

due randomization sirolimus-polymer-free eluting stent was implanted

Intervention Type: DEVICE

Other Intervention Names

Cypher®; ISAR Rapa G1

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Klaus Tiroch, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Muenchen

Locations

Deutsches Herzzentrum Muenchen

Munich, Bavaria, Germany

Site Status: RECRUITING

Klinikum rechts der Isar

Munich, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Julinda Mehilli, MD

Role: CONTACT

mehilli@dhm.mhn.de

+49 89 12 18 ext. 4582

Klaus Tiroch, MD

Role: CONTACT

tiroch@dhm.mhn.de

+49 89 12 18 ext. 4578

Facility Contacts

Julinda Mehilli, MD

Role: primary

mehilli@dhm.mhn.de

+49 89 12 18 ext. 4582

Klaus Tiroch, MD

Role: backup

tiroch@dhm.mhn.de

+49 89 12 18 ext. 4578

Steffen Massberg, MD

Role: primary

massberg@dhm.mhn.de

+49 89 12 18 ext. 4025

Other Identifiers

GE IDE No. S03310

Identifier Type: -

Identifier Source: org_study_id