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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Sirolimus eluting stent; Device: Paclitaxel-eluting stent

• Registration Number: NCT00598715
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-01-21
• Study First Posted: 2008-01-22
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2009-09
• Last Update Submitted: 2010-12-16
• Last Update Posted: 2010-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Same drug	Sirolimus eluting stent	sirolimus-eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent
Different drug	Paclitaxel-eluting stent	paclitaxel eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent

Primary Outcome Measures

Name	Time	Method
Late luminal loss at follow-up angiography	6-8 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Germany

1. Medizinische Klinik, Klinikum rechts der Isar; 🇩🇪 Munich, Germany