Non-Polymer-Based, Rapamycin-Eluting Stents to Prevent Restenosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Translumina GmbH.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Translumina GmbH
ClinicalTrials.gov Identifier:
NCT00152308
First received: September 8, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Prospective, Placebo-Controlled, Double-Blind, Randomized Study Evaluating the Efficacy of Non-Polymer-Based Coating With Two Different Rapamycin-Dosages for the Prevention of Restenosis After Percutaneous Coronary Interventions

Resource links provided by NLM:


Further study details as provided by Translumina GmbH:

Primary Outcome Measures:
  • Binary angiographic restenosis at follow-up angiogram

Secondary Outcome Measures:
  • Target vessel failure (all-cause death, myocardial infarction, or revascularization of the target lesion)

Estimated Enrollment: 333
Study Start Date: December 2004
Estimated Study Completion Date: February 2007
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152308

Contacts
Contact: Gisela Schoemig +49 89 2102 8920 Gisela.Schoemig@translumina.de

Locations
Austria
St. Johanns Spital Recruiting
Salzburg, Austria, 5020
Contact: Mathias Heigert, MD       M.heigert@salk.at   
Principal Investigator: Mathias Heigert, MD         
Allgemeines Krankenhaus Wien Recruiting
Vienna, Austria, 1090
Contact: Dietmar Glogar, MD       helmut-dietmar.glogar@univie.ac.at   
Principal Investigator: Dietmar Glogar, MD         
Wilhelminenspital der Stadt Wien Recruiting
Vienna, Austria, 1160
Contact: Kurt Huber, MD    +43 1 49150 0    kurt.huber@meduniwien.ac.at   
Principal Investigator: Kurt Huber, MD         
Donauspital der Stadt Wien Recruiting
Vienna, Austria, 1020
Contact: Georg Norman, MD    +43 1 28802      
Principal Investigator: Georg Norman, MD         
Germany
Deutsches Herzzentrum Muenchen Recruiting
Munich, Germany, 80636
Contact: Adnan Kastrati, MD    +49 89 1218 4577    kastrati@dhm.mhn.de   
Principal Investigator: Adnan Kastrati, MD         
First Medizinische Klinik rechts der Isar Recruiting
Munich, Germany, 81675
Contact: Josef , Dirschinger    +49 89 4140 2947    dirschinger@med1.med.tu-muenchen.de   
Principal Investigator: Josef Dirschinger, MD         
Kardiologische Praxis und Praxisklinik Recruiting
Munich, Germany, 81379
Contact: Sigmund Silber, MD    +49 89 742 15130    sigmund@silber.com   
Principal Investigator: Sigmund Silber, MD         
Israel
Hadassah University Hospital Recruiting
Jerusalem, Israel, 91120
Contact: Chaim Lotan, MD       Lotan@hadassah.org.il   
Principal Investigator: Chaim Lotan, MD         
Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Hylton Miller, MD       himiller@tasmc.health.gov.il   
Principal Investigator: Hylton Miller, MD         
Assaf Harofeh Medical Center Recruiting
Zrifin, Israel, 70300
Contact: Ricardo Krakover, MD    +972 08 9779738      
Principal Investigator: Ricardo Krakover, MD         
Sponsors and Collaborators
Translumina GmbH
Investigators
Study Chair: Albert Schomig, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
Study Director: Kurt Huber, MD Wilhelminenspital der Stadt Wien
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00152308     History of Changes
Other Study ID Numbers: GE IDE No. S01903
Study First Received: September 8, 2005
Last Updated: September 8, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 23, 2014