A Study of the Cypher SES to Treat Restenotic Native Coronary Artery Lesions.

Study Overview
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Brief Summary
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The main objective of this study is to assess the safety and effectiveness of the Cypher™ sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an in-stent restenotic native coronary artery lesion.

Detailed Description
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This is a multicenter (11 sites), non-randomized study. Patients who meet the eligibility criteria will be treated with the Cypher™ sirolimus-eluting stent. All patients will have a repeat angiography at six months post-procedure and will be additionally followed clinically at 1, 6 and 9 months and up to 3 years. The results of this study will be compared with the outcome of the GAMMA I / II as the historical control.

Official Title
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A Multi-Center, Non-Randomised Study of the CYPHER™ Sirolimus-Eluting Stent in the Treatment of Patient With an in-Stent Restenotic Native Coronary Artery Lesion

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: drug-eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient has an in-stent restenosis of ≥ 60% and < 100% (by QCA online of the MLD compared to the distal reference diameter) in a native coronary artery. The 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. Exclusion Criteria: Unprotected left main coronary disease with ≥ 50% stenosis; Patient previously treated with brachytherapy in any coronary vessel. Target lesion involves bifurcation including a side branch >2.5mm in diameter. The patient sustained a recent (<72 hours) myocardial infarction defined as a serum CK 2x the upper limit of normal and elevated MB or abnormal lab values.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Cypher™ sirolimus-eluting stent | Device: drug-eluting stent<br>* PCI<br>* Other names: Cypher™ sirolimus-eluting stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| angiographic in-lesion late loss |  | 6 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-stent mean percent diameter stenosis (%DS) |  | 6-months post-procedure | 
| i-stent late loss (LL) |  | 6 months post-procedure | 
| in-lesion binary restenosis |  | 6-months post-procedure | 
| Target Vessel Revascularization (TVR) |  | 9-months post-procedure | 
| Target Vessel Failure (TVF) defined as any revascularization of the index vessel or myocardial infarction or death that cannot be clearly attributed to a vessel other than the index vessel |  | 9 months post-procedure | 
| Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization in-hospital |  | 1, 6, 9 months and, 2 and 3 years post-procedure | 
| occurrence of bleeding |  | 1, 6, 9 months and, 2 and 3 years post-procedure |