Randomized Trial of Paclitaxel- vs Sirolimus-eluting Stents for Treatment of Coronary Restenosis in Sirolimus-eluting Stents
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Deutsches Herzzentrum Muenchen
- Enrollment
- 450
- Locations
- 2
- Primary Endpoint
- Late luminal loss at follow-up angiography
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Late luminal loss at follow-up angiography
Time Frame: 6-8 months
Secondary Outcomes
- 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)