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

March 1, 2011 updated by: ITGI Medical

OVER AND UNDER/ANEUGRAFT PERICARDIUM COVERED STENT Long Term Follow Up Registry

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting for PCI.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MACE (Major Adverse Clinical Events)
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ITGI Medical

Investigators

  • Principal Investigator: Asif Qasim, Kings College Hospital London
  • Principal Investigator: Morris Mosseri, MD, Sapir Health Center, Cfar Saba, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

March 1, 2011

First Submitted That Met QC Criteria

March 1, 2011

First Posted (Estimate)

March 3, 2011

Study Record Updates

Last Update Posted (Estimate)

March 3, 2011

Last Update Submitted That Met QC Criteria

March 1, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • Sleeve III

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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