Aneurysmal Coronary Arteries, Diseased Saphenous Vein Grafts
Conditions
Brief summary
The purpose of this study is to track the clinical safety and effectiveness of the Pericardium Covered Stent in real world use.
Detailed description
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.
Interventions
DEVICEPericardium Covered Stent
Percutaneous implantation of pericardium covered stent
Sponsors
ITGI Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MACE (Major Adverse Clinical Events) | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 30 days, 1 Year, 2 Years, 3 Years | 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 |
| Hospital readmission due to cardiac reason. | 30 days, 6 months. 1 Year, 2 Years, 3 Years | — |
Countries
Israel, United Kingdom
Contacts
Primary ContactMatthew Lewis, MD
Backup ContactShimon Lobel
Outcome results
None listed