3 Limus Agent Eluting Stents With Different Polymer Coating

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-04-30

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.

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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.

Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BPRES

biodegradable polymer rapamycin-eluting stent

Group Type EXPERIMENTAL

biodegradable polymer Rapamycin-eluting stent

Intervention Type DEVICE

due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted

PPRES

permanent polymer rapamycin-eluting stent

Group Type ACTIVE_COMPARATOR

permanent polymer rapamycin-eluting stent (Cypher)

Intervention Type DEVICE

due to randomization, rapamycin-eluting stent with permanent polymer will be implanted

PPEES

permanent polymer everolimus-eluting stent

Group Type ACTIVE_COMPARATOR

permanent polymer everolimus-eluting stent (Xience, Promus)

Intervention Type DEVICE

due to randomization, everolimus-eluting stent with permanent polymer will be implanted

Interventions

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biodegradable polymer Rapamycin-eluting stent

due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted

Intervention Type DEVICE

permanent polymer rapamycin-eluting stent (Cypher)

due to randomization, rapamycin-eluting stent with permanent polymer will be implanted

Intervention Type DEVICE

permanent polymer everolimus-eluting stent (Xience, Promus)

due to randomization, everolimus-eluting stent with permanent polymer will be implanted

Intervention Type DEVICE

Other Intervention Names

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ISAR stent Cypher Xience Promus

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No