Test Safety and Efficacy of Zotarolimus- and Everolimus-Eluting Stents (ZES/EES) Assessed by Optical Coherence Tomography

NCT ID: NCT01230723

Last Updated: 2012-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-07-31

Brief Summary

The objective of the study is to assess the superiority of the everolimus-eluting stent (Endeavor Resolute®) compared with the everolimus-eluting stent (XIENCE V®) regarding uncovered stent strut segments.

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.

Conditions

Coronary Heart Disease

Study Design

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

Study Groups

Arm 1

Everolimus-Eluting Stent

Group Type: ACTIVE_COMPARATOR

Everolimus-Eluting-Stent

Intervention Type: DEVICE

due randomization everolimus-eluting-stent will be implanted

Arm 2

Zotarolimus-Eluting-Stent

Group Type: ACTIVE_COMPARATOR

Zotarolimus-Eluting-Stent

Intervention Type: DEVICE

due randomization zotarolimus-eluting-stent will be implanted

Interventions

Everolimus-Eluting-Stent

due randomization everolimus-eluting-stent will be implanted

Intervention Type: DEVICE

Zotarolimus-Eluting-Stent

due randomization zotarolimus-eluting-stent will be implanted

Intervention Type: DEVICE

Other Intervention Names

Xience-V®; Endeavor Resolute®

Eligibility Criteria

Inclusion Criteria

• Patients older than age 18 with 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.
• In women with childbearing potential a negative pregnancy test is mandatory.

Exclusion Criteria

• Lesion length >16mm requiring a stent length >18mm
• Target lesion located in the left main trunk.
• In-stent restenosis.
• Acute myocardial infarction
• Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
• Known allergy to the study medications: everolimus, zotarolimus, stainless steel or cobalt chrome.
• Inability to take dual antiplatelet therapy for at least 6 months.
• Pregnancy (present, suspected or planned) or positive pregnancy test.
• Previous enrollment in this trial.
• 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

Klinikum rechts der Isar

Munich, Bavaria, Germany

Countries

Germany

Other Identifiers

GE IDE No. S03210

Identifier Type: -

Identifier Source: org_study_id