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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01307553
Recruitment Status : Unknown
Verified March 2011 by ITGI Medical.
Recruitment status was:  Recruiting
First Posted : March 3, 2011
Last Update Posted : March 3, 2011
Information provided by:
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.

Condition or disease Intervention/treatment
Diseased Saphenous Vein Grafts Aneurysmal Coronary Arteries Device: Pericardium Covered Stent

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.

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2010
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : April 2015

Group/Cohort Intervention/treatment
PCS Group Device: Pericardium Covered Stent
Percutaneous implantation of pericardium covered stent
Other Names:
  • Over and Under
  • Aneugraft

Primary Outcome Measures :
  1. MACE (Major Adverse Clinical Events) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. MACE [ Time Frame: 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

  2. Hospital readmission due to cardiac reason. [ Time Frame: 30 days, 6 months. 1 Year, 2 Years, 3 Years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting for PCI.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01307553

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Contact: Matthew Lewis, MD +972722200338
Contact: Shimon Lobel +972722200351

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Sapir Health Center Not yet recruiting
Cfar Saba, Israel
Contact: Morris Mosseri, MD   
United Kingdom
Kings College Hospital Recruiting
London, United Kingdom
Contact: Asif Qasim, MA PhD MRCP   
Sponsors and Collaborators
ITGI Medical
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Principal Investigator: Asif Qasim Kings College Hospital London
Principal Investigator: Morris Mosseri, MD Sapir Health Center, Cfar Saba, Israel
Publications of Results:
Other Publications:

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Responsible Party: VP Medical Affairs, ITGI Medical Identifier: NCT01307553    
Other Study ID Numbers: Sleeve III
First Posted: March 3, 2011    Key Record Dates
Last Update Posted: March 3, 2011
Last Verified: March 2011