Test Safety of Biodegradable and Permanent Limus-Eluting Stents Assessed by Optical Coherence Tomography

NCT ID: NCT01097434

Last Updated: 2012-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-05-31

Brief Summary

The objective of the study is to assess the superiority of the biodegradable polymer based limus-eluting stent (Nobori®) compared with the permanent polymer based everolimus-eluting stent (XIENCE V®) regarding absolute percentage of 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

Biodegradable polymer limus-eluting stents

Group Type: ACTIVE_COMPARATOR

Biodegradable polymer limus-eluting stents

Intervention Type: DEVICE

due randomization biodegradable polymer limus-eluting stents will be implanted

Arm 2

Permanent polymer limus-eluting stent

Group Type: ACTIVE_COMPARATOR

Permanent polymer limus-eluting stent

Intervention Type: DEVICE

due randomization permanent polymer limus-eluting stent will be implanted

Interventions

Biodegradable polymer limus-eluting stents

due randomization biodegradable polymer limus-eluting stents will be implanted

Intervention Type: DEVICE

Permanent polymer limus-eluting stent

due randomization permanent polymer limus-eluting stent will be implanted

Intervention Type: DEVICE

Other Intervention Names

Nobori®; Xience-V®

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: rapamycin, everolimus, biolimus, 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

Julinda Mehilli, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Muenchen

Locations

Deutsches Herzzentrum Muenchen

Munich, , Germany

Countries

Germany

Other Identifiers

GE IDE No. S03110

Identifier Type: -

Identifier Source: org_study_id