3 Limus Agent Eluting Stents With Different Polymer Coating

Study Overview
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Brief Summary
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The aim of this study is to determine whether biodegradable polymer based rapamycin-eluting stent performs equal to permanent polymer based everolimus- and rapamycin-eluting stents regarding reduction of adverse cardiac events at one year.

Detailed Description
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Drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare metal stents. Although this applies to the vast majority of patients, intimal hyperplasia and in-stent restenosis have not been completely eliminated and remain to occur in certain high risk subgroups. Thus there is ongoing research for new, potentially more effective and safe drug-eluting stent systems. One direction of extensive research is the search of new polymers such as biodegradable polymers which allow a controlled drug-release and disappear with time, reducing the probability of polymer-induced chronic inflammation on the vessel wall. Another direction is finding new drugs to suppress neointimal hyperplasia. Promising preclinical and clinical results suggest that the Everolimus eluting stent platform might provide potential improvements over prior generations of drug-eluting stents.

Official Title
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Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting STents (ISAR-TEST 4): Prospective, Randomized Trial of 3-limus Agent-eluting Stents With Different Polymer Coatings

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: biodegradable polymer Rapamycin-eluting stent
* Device: permanent polymer rapamycin-eluting stent (Cypher)
* Device: permanent polymer everolimus-eluting stent (Xience, Promus)


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% de novo 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. Target lesion located in the bypass graft. In-stent restenosis. 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: Clopidogrel, Rapamycin, Everolimus, stainless steel or cobalt chrome. Inability to take clopidogrel 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 |
| --- | --- |
| Experimental: BPRES<br>biodegradable polymer rapamycin-eluting stent | Device: biodegradable polymer Rapamycin-eluting stent<br>* due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted<br>* Other names: ISAR stent;|
| Active Comparator: PPRES<br>permanent polymer rapamycin-eluting stent | Device: permanent polymer rapamycin-eluting stent (Cypher)<br>* due to randomization, rapamycin-eluting stent with permanent polymer will be implanted<br>* Other names: Cypher;|
| Active Comparator: PPEES<br>permanent polymer everolimus-eluting stent | Device: permanent polymer everolimus-eluting stent (Xience, Promus)<br>* due to randomization, everolimus-eluting stent with permanent polymer will be implanted<br>* Other names: Promus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point of the study is a combined endpoint of cardiac death, myocardial infarction related to the target vessel or revascularization related to the target lesion. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment binary restenosis at follow-up angiography |  | 6-8 months | 
| Late Lumen Loss at follow-up angiography |  | 6-8 months | 
| All cause mortality. |  | 12 months | 
| Incidence of stent thrombosis (by ARC definition) |  | 12 months |