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

Coronary Heart Disease Clinical Trial

— ZES/EES-OCT  

Official title:

RANDOMIZED TRIAL OF ZOTAROLIMUS- AND EVEROLIMUS-ELUTING STENTS REGARDING STENT COVERAGE ASSESSED BY OCT

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01230723
• Other study ID #: GE IDE No. S03210
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 28, 2010
• Last updated: May 7, 2012
• Start date: October 2010
• Est. completion date: July 2012

Study information

• Verified date: May 2012
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: 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:
• Everolimus-Eluting-Stent
due randomization everolimus-eluting-stent will be implanted
• Zotarolimus-Eluting-Stent
due randomization zotarolimus-eluting-stent will be 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 assessed by OCT for each visible strut segment		6-8 months	Yes
Secondary	Percentage of malapposed strut assessed by OCT		6-8 months	Yes
Secondary	Percentage of uncovered malapposed struts assessed by OCT		6-8 months	Yes