Over and Under/Aneugraft Pericardium Covered Stent Long Term Follow up Registry

Study Overview
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Brief Summary
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The purpose of this study is to track the clinical safety and effectiveness of the Pericardium Covered Stent in real world use.

Detailed Description
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This is a multi-center registry of 75 patients treated with the Over and Under/Aneugraft Pericardium Covered Stent (PCS) (IGTI, Israel). The registry will involve the collection of demographic, clinical, and angiographic data on the treated patient population, including in-hospital, 30 day, 6-month, 1 year, 2 years and 3 years clinical follow-up data.

Official Title
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OVER AND UNDER/ANEUGRAFT PERICARDIUM COVERED STENT Long Term Follow Up Registry

Conditions
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Diseased Saphenous Vein Grafts, Aneurysmal Coronary Arteries

Intervention / Treatment
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* Device: Pericardium Covered Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is older than 18 years Patient must be available for follow-up Patient must be fully informed, provided with the patient information sheet and sign the Informed Consent Form prior to the procedure. The lesion to be treated should be suitable for treatment with a PCS in that: A. A suitable length and diameter PCS should be available B. For SVG disease a single or multiple PCS may be used C. For native coronary artery aneurysms the operator should be confident that the aneurysm may be excluded by the implantation of a single PCS Exclusion Criteria: Significant co-morbidity precluding clinical follow-up. Pregnancy; pregnancy test negative in women with child bearing potential Acute ST-elevation myocardial infarction within the preceding 48 hours Previous stent implantation in the target vessel Left main coronary artery disease Contra-indication to dual anti-platelet therapy. Planned surgery which will lead to discontinuation of antiplatelet therapy Thrombocytopenia (<100,000/mm3) Ejection fraction <30%. Renal failure (creatinine >180 µmol/L [2 mg/dL]) Prior brachytherapy Recipient of heart transplant Acute infections

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCS Group<br> | Device: Pericardium Covered Stent<br>* Percutaneous implantation of pericardium covered stent<br>* Other names: Aneugraft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE (Major Adverse Clinical Events) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | MACE is a composite end point of cardiac death, myocardial infarction and target vessel revascularisation (TVR). Each one of the MACE components will be recorded separately | 30 days, 1 Year, 2 Years, 3 Years | 
| Hospital readmission due to cardiac reason. |  | 30 days, 6 months. 1 Year, 2 Years, 3 Years |