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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Comparison of Limus-Eluting Stents With Biodegradable or Permanent Polymer Coating Regarding Stent Coverage Assessed by Optical Coherence Tomography

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: Biodegradable polymer limus-eluting stents
* Device: Permanent polymer limus-eluting stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Biodegradable polymer limus-eluting stents | Device: Biodegradable polymer limus-eluting stents<br>* due randomization biodegradable polymer limus-eluting stents will be implanted<br>* Other names: Nobori®;|
| Active Comparator: Arm 2<br>Permanent polymer limus-eluting stent | Device: Permanent polymer limus-eluting stent<br>* due randomization permanent polymer limus-eluting stent will be implanted<br>* Other names: Xience-V®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of uncovered stent strut segments assessed by OCT |  | 6-8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of malposed stent strut segments assessed by OCT |  | 6-8 months |