3 Limus Agent Eluting Stents With Different Polymer Coating
- Conditions
- Coronary Heart Disease
- Interventions
- Device: biodegradable polymer Rapamycin-eluting stentDevice: permanent polymer rapamycin-eluting stent (Cypher)Device: permanent polymer everolimus-eluting stent (Xience, Promus)
- Registration Number
- NCT00598676
- Lead Sponsor
- Deutsches Herzzentrum Muenchen
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2600
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BPRES biodegradable polymer Rapamycin-eluting stent biodegradable polymer rapamycin-eluting stent PPRES permanent polymer rapamycin-eluting stent (Cypher) permanent polymer rapamycin-eluting stent PPEES permanent polymer everolimus-eluting stent (Xience, Promus) permanent polymer everolimus-eluting stent
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (2)
Medizinische Klinik, Klinikum rechts der Isar
🇩🇪Muenchen, Germany
Deutsches Herzzentrum Muenchen
🇩🇪Munich, Germany