The Intra-Drug Eluting Stent (DES) Restenosis Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: drug-eluting stent and balloon angioplasty
* Device: drug-eluting stent and balloon angioplasty
* Device: drug-eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia; Patient has an intra-DES (TAXUS™ OR CYPHER™) or intra-BMS restenosis of >= 50% and <100% (by QCA online of the MLD compared to the distal reference diameter) in a native coronary artery; Study target lesion must be located in a restenotic native coronary artery >=2.25mm and <=3.5mm in lumen diameter and <=30mm in length by visual estimate and within a region up to 5mm to the proximal/distal stent edge; Study target lesion must have undergone coronary interventional treatment >= 4 weeks previously. Patients with one ore more prior PTCA procedures at the target lesion are acceptable candidates. Study target lesion can not be located in a vessel containing another lesion requiring treatment. Lesions located in other vessels may be treated with percutaneous revascularization at the time of the procedure, BUT they must be successfully treated prior to the treatment of the study target lesion; Patient is candidate for a current percutaneous revascularisation technique; Patient is willing to comply with the specified follow-up evaluations (including angiographic follow-up); Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee; Exclusion Criteria: Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK >2 times normal within the preceding 72 hours and the CK enzymes remain above normal at the time of treatment; Has unstable angina classified as Braunwald A I-II-III; Unprotected left main coronary disease with ³50% stenosis; Significant (>50%) stenoses of additional lesions proximal or distal to the target lesion(s) that might require revascularization or impede runoff; Target lesion is in an internal mammary artery, saphenous vein bypass graft or is located in the left main or is ostial; Stent implantation(s) is a non-elective, emergency procedure; Stent at the target restenosed lesion is neither TAXUS™ , CYPHER™ DES nor a BMS; Documented left ventricular ejection fraction <=25%; Totally occluded vessel (TIMI 0 level).

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>group with intra-Cypher™ restenosis | Device: drug-eluting stent and balloon angioplasty<br>* CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand<br>|
| Active Comparator: 2<br>group with intra-Taxus™ restenosis | Device: drug-eluting stent and balloon angioplasty<br>* CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand<br>|
| Active Comparator: 3<br>group with intra-BMS restenosis | Device: drug-eluting stent<br>* CYPHER Select ™ Sirolimus-eluting Stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In stent late loss. |  | between 9 - 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent, in-segment, and in-lesion binary restenosis rate by QCA. |  | between 9 - 12 months | 
| In-lesion late loss as assessed by QCA. |  | between 9 - 12 months | 
| In-stent and in-lesion MLD, and percent diameter stenosis (%DS) as assessed by QCA. |  | between 9 - 12 months | 
| Target lesion revascularization (TLR). |  | 30 days, 6 and 12 months | 
| Target vessel revascularization (TVR). |  | 30 days, 6 and 12 months | 
| Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization. |  | 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. |  | 30 days, 6 months and 12 months |