Coronary Artery Disease
Conditions
Keywords
In-stent restenosis, In-DES-restenosis, paclitaxel, sirolimus
Brief summary
For lesions which develop restenosis after a drug-eluting stent, 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.
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
Interventions
DEVICESirolimus eluting stent
Sirolimus-eluting stent will be implanted
DEVICEPaclitaxel-eluting stent
Paclitaxel-eluting stent will be implanted
Sponsors
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late luminal loss at follow-up angiography | 6-8 months |
Secondary
| Measure | Time frame |
|---|---|
| Need of target lesion revascularization. | 12 months |
| Combined incidence of death or myocardial infarction. | 12 months |
| Incidence of stent thrombosis. | 12 months |
| Incidence of binary restenosis at follow-up angiography | 6-8 months |
Countries
Germany
Outcome results
None listed