Over and Under/Aneugraft Pericardium Covered Stent Long Term Follow up Registry (Sleeve III)

ITGI Medical

Status: Unknown

Conditions: Aneurysmal Coronary Arteries; Diseased Saphenous Vein Grafts

Treatments: Device: Pericardium Covered Stent

Study type: Observational

Funder types: Industry

Identifiers

NCT01307553

Sleeve III

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

75 participants in 1 patient group

PCS Group

Treatment:

Device: Pericardium Covered Stent