RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent.

Study Overview
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Brief Summary
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Context: Sirolimus-eluting-stents have improved the benefits of percutaneous interventions in native coronary arteries reducing the occurrence of restenosis and repeated revascularization, however saphenous vein grafts have been always excluded form randomized trials. Objective: To evaluate the angiographic and clinical impact of sirolimus-eluting-stents with respect to bare-metal-stents in degenerated vein grafts. Design: Double-blind randomized controlled non-industry-sponsored trial. Setting: A single-center tertiary-care referral hospital. Patients: All patients are randomly allocated to sirolimus-eluting-stent implantation or the corresponding bare-metal-stent. All patients are followed clinically and repeated angiographic follow-up is performed in all at 6-months. Main outcome measure: Primary end-point is 6-months angiographic in-stent late loss. Secondary end-points include: binary angiographic in-stent and in-segment restenosis, intravascular-ultrasound-measured neo-intimal hyperplasia volume and all the clinical events (death, myocardial infarction, target-lesion and target-vessel revascularization).

Official Title
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Phase 2 Randomized Double-Blind Comparison of Sirolimus-Eluting Stent Versus Bare-Metal Stent Implantation in Degenerated Saphenous Vein Grafts

Conditions
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Stable Angina, Unstable Angina, Coronary Artery Disease, Saphenous Vein Graft Disease

Intervention / Treatment
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* Device: sirolimus-eluting stent
* Device: bare metal stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 85 years-old clear signs and/or symptoms of stable or unstable angina or documented silent ischemia one or more de-novo target lesions (>50% diameter stenosis by visual estimate) localized in one or more diseased SVG with a reference vessel diameter (RVD) included between 2.5 and 4.0 mm (by visual estimate) signed informed consent. Exclusion Criteria: Myocardial Infarction within the previous 7 days documented left ventricular ejection fraction <25% impaired renal function (creatinine >3.0 mg/dl) at the time of treatment outflow obstruction of the graft due to distal anastomotic stenosis totally occluded Saphenous Vein Graft brachytherapy treatment in the index vessel before enrollment life expectancy less than 12 months known allergy to aspirin, clopidogrel bisulfate, heparin, stainless steel, contrast agent or sirolimus hemorrhagic diatheses a recent positive pregnancy test, breast-feeding, or the possibility of a future pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: sirolimus-eluting stent|nan|
|Device: bare metal stent|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent late loss |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-segment late loss |  |  | 
| binary angiographic in-stent restenosis |  |  | 
| binary angiographic in-segment restenosis |  |  | 
| intravascular-ultrasound-measured neo-intimal hyperplasia volume |  |  | 
| death |  |  | 
| myocardial infarction |  |  | 
| target-lesion revascularization |  |  | 
| target-vessel revascularization |  |  | 
| stent thrombosis |  |  |