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Intravascular Stents Fracture Effects

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ClinicalTrials.gov Identifier: NCT01382381
Recruitment Status : Unknown
Verified February 2011 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : June 27, 2011
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The goal of the study is to evaluate long term durability and hemodynamic effect of implanted stents in the aortic arch and in pulmonary artery branches.

Condition or disease
Durability of Implanted Intravascular Stents Hemodynamic Effect of Implanted Intravascular Stents

Detailed Description:

Patients who underwent trans-catheter implantation of balloon expanded stents in the aortic arch and in branch pulmonary arteries will be evaluated by physical examination with blood pressure values measurement of upper and lower limbs.

Echo-Doppler cardiography will be performed for flow velocity analysis. Zoomed fluoroscopy will be performed and recorded in two orthogonal views to evaluate stent integrity or stent fracture.

It is our intention to include 20 patients in this study from our follow-up clinic.


Study Design

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Implanted Aortic Arch and Branch Pulmonary Artery Stents Durability and Function
Study Start Date : July 2011
Estimated Study Completion Date : July 2012
Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Twenty patients who underwent stent implantation for coarctation of the aorta and for branch pulmonary artery stenosis will be recruited for the study from our out-patients follow-up clinic
Criteria

Inclusion Criteria:

-patients who underwent stent implantation for coarctation of the aorta and for branch pulmonary artery stenosis

Exclusion Criteria:

-Pregnancy

More Information

Responsible Party: Prof. Avraham Lorber, Head, Pediatric Cardiology and Adults with Congenital Heart Disease, Rambam Medical Center, P.O.B 9602, Haifa 31096, Israel
ClinicalTrials.gov Identifier: NCT01382381     History of Changes
Other Study ID Numbers: 0081CTIL
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: February 2011