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

• Conditions: Diseased Saphenous Vein Grafts; Aneurysmal Coronary Arteries
• Interventions: Device: Pericardium Covered Stent

• Registration Number: NCT01307553
• Lead Sponsor: ITGI Medical

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.

Study Timeline

• Study Start: 2010-09
• Status Verified: 2011-03
• Study First Submitted: 2011-03-01
• Study First Submitted QC: 2011-03-01
• Last Update Submitted: 2011-03-01
• Study First Posted: 2011-03-03
• Last Update Posted: 2011-03-03
• Primary Completion: 2012-10
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PCS Group	Pericardium Covered Stent	-

Primary Outcome Measures

Name	Time	Method
MACE (Major Adverse Clinical Events)	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Sapir Health Center; 🇮🇱 Cfar Saba, Israel

Kings College Hospital; 🇬🇧 London, United Kingdom