Efficacy Study of Two Different Strategies for Restenosis in Sirolimus-Eluting Stents (DESIRE-2)

German Heart Center Munich

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: Paclitaxel-eluting stent; Device: Sirolimus eluting stent

Study type: Interventional

Funder types: Other

Identifiers

NCT00598715

GE IDE No. S02407

Details and patient eligibility

About

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.

Full 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

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 2 patient groups

Same drug

Experimental group

Description:

sirolimus-eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent

Treatment:

Device: Sirolimus eluting stent

Different drug

Active Comparator group

Description:

paclitaxel eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent

Treatment:

Device: Paclitaxel-eluting stent