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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2011 by ITGI Medical
Sponsor:
Information provided by:
ITGI Medical
ClinicalTrials.gov Identifier:
NCT01307553
First received: March 1, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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


Condition Intervention
Diseased Saphenous Vein Grafts
Aneurysmal Coronary Arteries
Device: Pericardium Covered Stent

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: OVER AND UNDER/ANEUGRAFT PERICARDIUM COVERED STENT Long Term Follow Up Registry

Further study details as provided by ITGI Medical:

Primary Outcome Measures:
  • MACE (Major Adverse Clinical Events) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • MACE [ Time Frame: 30 days, 1 Year, 2 Years, 3 Years ] [ Designated as safety issue: Yes ]

    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. [ Time Frame: 30 days, 6 months. 1 Year, 2 Years, 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: September 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PCS Group Device: Pericardium Covered Stent
Percutaneous implantation of pericardium covered stent
Other Names:
  • Over and Under
  • Aneugraft

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting for PCI.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307553

Contacts
Contact: Matthew Lewis, MD +972722200338 matthewl@itgimedical.com
Contact: Shimon Lobel +972722200351 shimonl@itgimedical.com

Locations
Israel
Sapir Health Center Not yet recruiting
Cfar Saba, Israel
Contact: Morris Mosseri, MD       morris.mosseri@clalit.org.il   
United Kingdom
Kings College Hospital Recruiting
London, United Kingdom
Contact: Asif Qasim, MA PhD MRCP       asif@g-cardio.net   
Sponsors and Collaborators
ITGI Medical
Investigators
Principal Investigator: Asif Qasim Kings College Hospital, London
Principal Investigator: Morris Mosseri, MD Sapir Health Center, Cfar Saba, Israel
  More Information

Publications:

Responsible Party: VP Medical Affairs, ITGI Medical
ClinicalTrials.gov Identifier: NCT01307553     History of Changes
Other Study ID Numbers: Sleeve III
Study First Received: March 1, 2011
Last Updated: March 1, 2011
Health Authority: United Kingdom: Research Ethics Committee
Israel: Ethics Commission

ClinicalTrials.gov processed this record on November 25, 2014