A Prospective, Randomized, Multi-Center Comparison of the Cypher Select™ Sirolimus-Eluting Stent and Balloon Re-Angioplasty for Treatment of Patients with Intra-Des Restenosis.
This is a prospective, randomized study to be conducted at up to 33 sites in France with 3 groups of patients (1 group with intra-Taxus™ restenosis, 1 group with intra-Cypher™ restenosis and 1 control group with intra-BMS restenosis). All patients will have a repeat angiography at 9 to 12 months post-procedure and will be followed up to 12 months post-procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand
CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand
CYPHER Select ™ Sirolimus-eluting Stent
Centre Cardiologique du Nord
Saint-Denis, France
Unite de Cardiologie Interventionelle
Toulouse, France
In stent late loss.
Time frame: between 9 - 12 months
In-stent, in-segment, and in-lesion binary restenosis rate by QCA.
Time frame: between 9 - 12 months
In-lesion late loss as assessed by QCA.
Time frame: between 9 - 12 months
In-stent and in-lesion MLD, and percent diameter stenosis (%DS) as assessed by QCA.
Time frame: between 9 - 12 months
Target lesion revascularization (TLR).
Time frame: 30 days, 6 and 12 months
Target vessel revascularization (TVR).
Time frame: 30 days, 6 and 12 months
Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization.
Time frame: 30 days, 6 and 12 months
Composite of Major Adverse Cardiac Events (MACE) defined as cardiac death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization.
Time frame: 30 days, 6 months and 12 months
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