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

German Heart Center Munich

Status and phase

Unknown

Phase 4

Conditions

Coronary Heart Disease

Treatments

Device: Zotarolimus-Eluting-Stent

Device: Everolimus-Eluting-Stent

Study type

Interventional

Funder types

Other

Identifiers

NCT01230723

GE IDE No. S03210

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.