Test Efficacy of Biodegradable and Permanent Limus-Eluting Stents

Study Overview
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Brief Summary
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The aim of this prospective, randomized study is to compare the efficacy and safety of biodegradable polymer based limus-eluting stents (BPDES) with permanent polymer based everolimus eluting stents (PPDES).

Detailed Description
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Restenosis affects 20-40% of de novo coronary lesions treated with bare-metal stents. Although it is often considered a benign process, recent data indicate that in-stent restenosis has a negative impact on long-term survival of patients treated with coronary stents. Drug eluting stents have emerged as the most effective strategy for the prevention of restenosis. A large number of studies showed that drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare-metal stents. Available evidence shows that all 3 limus drugs - rapamycin, everolimus and biolimus - are very effective in suppressing neointima formation after coronary stenting. Drugs are fully released within a few weeks from the majority of current DES. However, most of the DES use permanent polymers, which continue to remain in the vessel wall even after accomplishing their drug-release mission. Their permanent presence may be associated with persistent inflammatory reaction and delayed neointimal proliferation and vessel thrombosis. Clinical trial evidence with biodegradable polymer DES is still limited, but there are great expectations that this DES technology might be the dominant one in the years to come.

Official Title
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Prospective, Randomized Trial of Limus-Eluting Stents With Biodegradable or Permanent Polymer Coatings

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: Nobori® (Biodegradable polymer limus-eluting stents)
* Device: Xience-V® (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: Target lesion located in the left main trunk. In-stent restenosis of DES. Cardiogenic shock. 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: BPLES<br>Biodegradable polymer limus-eluting stents | Device: Nobori® (Biodegradable polymer limus-eluting stents)<br>* due randomization biodegradable polymer limus-eluting stents will be implanted<br>* Other names: ISAR G2;|
| Active Comparator: PPLES<br>Permanent polymer limus-eluting stent | Device: Xience-V® (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 |
| --- | --- | --- |
| A composite endpoint of cardiac death, myocardial infarction related to the target vessel or revascularisation related to the target lesion. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite of all cause mortality or myocardial infarction |  | 6-8 months | 
| Stent thrombosis |  | 6-8 months | 
| Late luminal loss |  | 6-8 months | 
| Binary angiographic restenosis |  | 6-8 months |