Coronary Artery Disease
Conditions
Keywords
cobalt chromium stent, paclitaxel coated balloon catheter, DEBlue, drug eluting balloon
Brief summary
The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting SeQuent Please S stent system (DEBlue) in the treatment of stenoses in native coronary arteries with nominal stent diameters between ≥ 2.5 mm and ≤ 3.5 mm and \< 24 mm in length for procedural success and preservation of vessel patency in comparison to the Sirolimus-eluting CypherTM stent.
Detailed description
The incidence of in-stent restenosis after percutaneous coronary intervention varies between 5 and 35% after bare metal stenting and is as high as 19% after the implantation of a drug-eluting stent in patients at moderate risk. Restenosis due to neointimal hyperplasia is a slow process, suggesting that therapeutic local drug administration would need to be prolonged to be beneficial. Stent-based local drug delivery provides sustained drug release using special release technologies like polymer coating. However, cell culture experiments indicate that even brief contact between vascular smooth muscle cells and lipophilic taxane compounds can inhibit vascular smooth muscle cell proliferation for a long period. In experiments in swine, intracoronary delivery of paclitaxel by contrast media or by a drug-coated balloon catheter was found to result in vascular tissue concentrations capable of producing antiproliferative effects, thus leading to a significant reduction in neointimal proliferation. In these animal studies, the most pronounced reduction of neointimal formation was seen with paclitaxel-coated balloon catheters.
Interventions
DEVICEDEBlue stent vs. Cypher stent
DES vs. DEB with BMS
Sponsors
B.Braun Vascular Systems, Berlin, Germany
University Hospital, Saarland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with stable or unstable angina or documented ischemia due to a significant lesion in a native coronary artery * 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
* Unprotected left main * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| late lumen loss | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| MACE | 9 months |
| Binary restenosis rate | 9 months |
Countries
Belgium, Czechia, France, Germany, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed