The purpose of the study is to evaluate the effectively of coating of coronary stents with two different doses of rapamycin for the prevention of coronary vessel re-blockage

Condition	Intervention	Phase
Coronary Disease	Device: 2% rapamycin-eluting YUKONdes PEARL-stent  Device: 1% rapamycin-eluting YUKONdes PEARL-stent  Device: YUKONdes PEARL-stent coated with placebo (ethanol)	Phase IV

Further Study Details: 

Primary Outcomes: Binary angiographic restenosis at follow-up angiogram
Secondary Outcomes: Target vessel failure (all-cause death, myocardial infarction, or revascularization of the target lesion)
Expected Total Enrollment:  333

In-stent restenosis remains the major problem limiting the efficacy of coronary stenting. Either sirolimus or paclitaxel drug-eluting stents have been demonstrated to decrease neointima proliferation resulting in a remarkable reduction of restenosis rate. However, despite the outstanding results achieved with this novel approach to restenosis, some caveats still remain. Although sirolimus markedly decreased the restenosis rate among diabetic patients in SIRIUS trial, the benefit of treatment was modest in those diabetics treated with insulin as well as with lesions longer than 15 mm located in vessels smaller than 2.5 mm. Additionally, in a recent study it was reported that the restenosis rate in high-risk lesions such as coronary bifurcations still remains a problem Data from patient populations other than those enrolled in randomized trials suggest even more caution in the evaluation of the impact of DES on restenosis in the “real world”, where the operator must deal with in-stent restenosis, bifurcation lesions, chronic total occlusions, small vessels, and long lesions. The identification of some of the traditional risk factors for restenosis as important predictors for in-DES restenosis could be explained as an insufficient inhibition of tissue reaction and neointimal growth by the antiproliferative action of the specific drug or dose used. This leads to the inference that an individualized approach should be adopted by tailoring the choice and the dosing of eluting drug(s) according to the specific lesion or patient characteristics. On the other hand, although drug-eluting stents are currently considered as the most effective way to reduce in-stent restenosis, their widespread use is hampered by the high costs. Therefore, it is important to develop new methods and techniques that would result in a more effective prevention of in-stent restenosis while being available for a larger number of patients. These considerations as well as the proven efficacy of rapamycin in lowering the rate of coronary restenosis, support the rationality of the concept of on-site coating of stents in the catheterization laboratory with individualized doses of rapamycin after the clinical and the angiographic profiles of the patient scheduled to coronary stenting have been determined

Ages Eligible for Study:  18 Years   -   85 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Age 18-85 years; Symptoms (stable or unstable angina) or signs of myocardial ischemia; Single de novo diagnosed lesion in a native coronary artery (50-99% DS); Lesion length 8 – 25 mm; Vessel diameter 2.25-3.75 mm; Written informed consent

Exclusion Criteria:

Left main target lesion unprotected by a graft; Ostial and bifurcation target lesion; Severely calcified lesions; Thrombus in target lesion; Tortuosity or angulation of target vessel or lesion; Treatment of nontarget lesions in the same or a different coronary vessel during the index procedure; Contraindications to the study medications; Acute myocardial infarction (< 48 h); Left ventricular ejection fraction < 25%; Participation in another trial; Pregnancy or lack of protection against pregnancy during the study Coexisting conditions limiting the life expectancy to less 24 months or that could affect the compliance of patients with protocol; Serum creatinin >2.0mg/dL; Hemorrhagic diathesis; Leukocyte count <3500/ml^3 Platelet count <100.000/ml^3

Please refer to this study by ClinicalTrials.gov identifier  NCT00152308

Gisela Schoemig      +49 89 2102 8920    Gisela.Schoemig@translumina.de

Austria
      Allgemeines Krankenhaus Wien, Vienna,  1090,  Austria; Recruiting
      Wilhelminenspital der Stadt Wien, Vienna,  1160,  Austria; Recruiting
      St. Johanns Spital, Salzburg,  5020,  Austria; Recruiting
      Donauspital der Stadt Wien, Vienna,  1020,  Austria; Recruiting
Germany
      Deutsches Herzzentrum Muenchen, Munich,  80636,  Germany; Recruiting
      First Medizinische Klinik rechts der Isar, Munich,  81675,  Germany; Recruiting
      Kardiologische Praxis und Praxisklinik, Munich,  81379,  Germany; Recruiting
Israel
      Hadassah University Hospital, Jerusalem,  91120,  Israel; Recruiting
      Assaf Harofeh Medical Center, Zrifin,  70300,  Israel; Recruiting
      Sourasky Medical Center, Tel Aviv,  64239,  Israel; Recruiting

Study chairs or principal investigators

Albert Schomig, MD,  Study Chair,  Deutsches Herzzentrum Muenchen   
Adnan Kastrati, MD,  Principal Investigator,  Deutsches Herzzentrum Muenchen   
Kurt Huber, MD,  Study Director,  Wilhelminenspital der Stadt Wien   

Study ID Numbers:  GE IDE No. S01903
Last Updated:  September 8, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00152308
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13