Efficacy Study of Two Different Strategies for Restenosis in Sirolimus-Eluting Stents

Study Overview
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Brief Summary
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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
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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

Official Title
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Randomized Trial of Paclitaxel- vs Sirolimus-eluting Stents for Treatment of Coronary Restenosis in Sirolimus-eluting Stents

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Sirolimus eluting stent
* Device: Paclitaxel-eluting stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Same drug<br>sirolimus-eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent | Device: Sirolimus eluting stent<br>* Sirolimus-eluting stent will be implanted<br>* Other names: Cypher;|
| Active Comparator: Different drug<br>paclitaxel eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent | Device: Paclitaxel-eluting stent<br>* Paclitaxel-eluting stent will be implanted<br>* Other names: Taxus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late luminal loss at follow-up angiography |  | 6-8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In-stent restenosis, In-DES-restenosis, paclitaxel, sirolimus