Drug Eluting Stents for In-Stent Restenosis 2 - Full Text View

Sponsors and Collaborators:	Deutsches Herzzentrum Muenchen Technische Universität München
Information provided by:	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT00598715

Purpose

For lesions which develop restenosis after a DES, it is not known which the right strategy to use is, implantation of the same type of DES as the initial one or a DES with a different drug.

Condition	Intervention	Phase
Coronary Artery Disease	Device: Sirolimus eluting stent (Cypher) Device: Paclitaxel-eluting stent	Phase IV

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Paclitaxel Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Prospective, Randomized Trial of Paclitaxel- vs Sirolimus-Eluting Stents for Treatment of Coronary Restenosis in Sirolimus-Eluting Stents

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:

Late luminal loss at follow-up angiography [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Need of target lesion revascularization. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Combined incidence of death or myocardial infarction. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Incidence of stent thrombosis. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	360
Study Start Date:	October 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental due to randomisation patients will get a Sirolimus eluting stent	Device: Sirolimus eluting stent (Cypher) Sirolimus eluting stent will be implanted
2: Experimental due to randomisation patients will get a Paclitaxel eluting stent	Device: Paclitaxel-eluting stent Paclitaxel eluting stent will be implanted (Taxus)

Detailed Description:

Treatment of in-stent restenosis after implantation of a DES has poorly been studied. Although there are no data, it may be assumed that certain lesions might be resistant to a given drug and in need of a different DES. Thus, for lesions which develop restenosis after a DES, it is not known which the right strategy to use is, implantation of the same type of DES as the initial one or a DES with a different drug. This prospective, randomized trial will compare the anti-restenotic efficacy of PES or SES in patients with restenosis after initial implantation of a SES

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of > 50% re- stenosis after prior implantation of Sirolimus eluting stents 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:

Cardiogenic shock
Acute myocardial infarction within the first 48 hours from symptom onset.
Target lesion located in the left main trunk or bypass graft.
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.
Allergy to antiplatelet therapy, sirolimus, paclitaxel, stainless steel.
Pregnancy (present, suspected or planned) or positive pregnancy test.
Previous enrollment in this trial.
Patient's inability to fully comply with the study protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598715

Contacts

Contact: Julinda Mehilli, MD	+49 89 1218 ext 4582	mehilli@dhm.mhn.de
Contact: Stefanie Schulz, MD	+49 89 1218 ext 1534	schulzs@dhm.mhn.de

Locations

Germany
Deutsches Herzzentrum Muenchen	Recruiting
Munich, Germany, 80636
Contact: Mehilli

Sponsors and Collaborators

Deutsches Herzzentrum Muenchen

Technische Universität München

Investigators

Principal Investigator:

Kastrati

Deutsches Herzzentrum Muenchen

More Information

Publications:

Kastrati A, Mehilli J, von Beckerath N, Dibra A, Hausleiter J, Pache J, Schühlen H, Schmitt C, Dirschinger J, Schömig A; ISAR-DESIRE Study Investigators. Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. JAMA. 2005 Jan 12;293(2):165-71.

Responsible Party:	Deutsches Herzzentrum Muenchen ( Prof. A. Schömig )
Study ID Numbers:	GE IDE No. S02407
Study First Received:	January 10, 2008
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00598715 History of Changes
Health Authority:	Germany: German Institute of Medical Documentation and Information

Keywords provided by Deutsches Herzzentrum Muenchen:

In-stent restenosis

Study placed in the following topic categories:

Arterial Occlusive Diseases
Sirolimus
Heart Diseases
Immunologic Factors
Clotrimazole
Miconazole
Myocardial Ischemia
Tioconazole
Vascular Diseases
Antimitotic Agents
Ischemia

Arteriosclerosis
Immunosuppressive Agents
Coronary Restenosis
Coronary Disease
Anti-Bacterial Agents
Paclitaxel
Antifungal Agents
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Coronary Artery Disease

Additional relevant MeSH terms:

Sirolimus
Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myocardial Ischemia
Physiological Effects of Drugs
Arteriosclerosis
Antibiotics, Antineoplastic
Anti-Bacterial Agents
Therapeutic Uses
Antifungal Agents
Cardiovascular Diseases

Arterial Occlusive Diseases
Heart Diseases
Mitosis Modulators
Vascular Diseases
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Coronary Disease
Paclitaxel
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009