Study Results
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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COMPLETED
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2007-07-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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DEBlue stent
Paclitaxel coated balloon with CoCr stent mounted on it
DEBlue vs Cypher vs BMS
BMS vs DES vs DEB+BMS
Cypher stent
DEBlue vs Cypher vs BMS
BMS vs DES vs DEB+BMS
Coroflex Blue stent
DEBlue vs Cypher vs BMS
BMS vs DES vs DEB+BMS
Interventions
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DEBlue vs Cypher vs BMS
BMS vs DES vs DEB+BMS
Eligibility Criteria
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Inclusion Criteria
* Patients eligible for coronary revascularization by means of PCI
* Intention to treat one lesion with one stent
* Patients suitable for coronary revascularization of any sort (balloon angioplasty, device-assisted balloon-angioplasty, or coronary artery bypass grafting)
* Patients must be ≥ 18 years of age
* Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the first year following the study procedure. Hence, patients will be advised to use an adequate birth control method up to and including 9 months follow-up
* Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol
* Patients must agree to undergo the 9 months angiographic follow-up
* Patients must agree to undergo the 1 and 3 year clinical follow-up
* Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g. balloon angioplasty by means of the Paclitaxel-eluting PTCA-balloon catheter in combination with the Coroflex BlueTM stent or the Sirolimus-eluting CypherTM stent. The patients, by providing informed consent, agree to these risks and benefits as stated in the patient informed consent document.
* Significant stenoses in native coronary arteries with nominal stent diameters between ≥ 2.5 mm and ≤ 3.5 mm and \< 24 mm in length
Exclusion Criteria
* In stent restenosis
* Indication for more than one lesion to treat, even as staged procedure
* Intended bifurcational stenting
* Patients requiring chronic anticoagulation
* SVG and AG
* Acute MI (STEMI, NSTEMI)
* Cardiogenic shock
* Chronic total occlusions
* Pregnancy
* Patients with stand alone balloon angioplasty, or stent deployment 6 months prior to enrolment into this study
18 Years
ALL
No
Sponsors
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University Hospital, Saarland
OTHER
Responsible Party
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University Hospital, Saarland
Principal Investigators
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Bruno Scheller
Role: PRINCIPAL_INVESTIGATOR
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes, Homburg/Saar, Germany
Locations
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Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
Homburg / Saar, Saarland, Germany
Countries
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References
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Scheller B, Speck U, Bohm M. Prevention of restenosis: is angioplasty the answer? Heart. 2007 May;93(5):539-41. doi: 10.1136/hrt.2007.118059.
Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.
Speck U, Scheller B, Abramjuk C, Breitwieser C, Dobberstein J, Boehm M, Hamm B. Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology. 2006 Aug;240(2):411-8. doi: 10.1148/radiol.2402051248.
Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. doi: 10.1161/01.CIR.0000138929.71660.E0. Epub 2004 Aug 9.
Inoue T, Sata M, Hikichi Y, Sohma R, Fukuda D, Uchida T, Shimizu M, Komoda H, Node K. Mobilization of CD34-positive bone marrow-derived cells after coronary stent implantation: impact on restenosis. Circulation. 2007 Feb 6;115(5):553-61. doi: 10.1161/CIRCULATIONAHA.106.621714. Epub 2007 Jan 29.
Clever YP, Cremers B, Speck U, Dietz U, Bohm M, Scheller B. Influence of a paclitaxel coated balloon in combination with a bare metal stent on restenosis and endothelial function: comparison with a drug eluting stent and a bare metal stent. Catheter Cardiovasc Interv. 2014 Aug 1;84(2):323-31. doi: 10.1002/ccd.25184. Epub 2013 Sep 30.
Other Identifiers
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BBM-VS54-HOM
Identifier Type: -
Identifier Source: org_study_id