Intravascular Stents Fracture Effects (no)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2011 by Rambam Health Care Campus.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Rambam Health Care Campus

ClinicalTrials.gov Identifier:

NCT01382381

First received: June 23, 2011

Last updated: June 24, 2011

Last verified: February 2011

History of Changes

Purpose

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
Durability of Implanted Intravascular Stents Hemodynamic Effect of Implanted Intravascular Stents

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Evaluation of Implanted Aortic Arch and Branch Pulmonary Artery Stents Durability and Function

Further study details as provided by Rambam Health Care Campus:

Estimated Enrollment:	20
Study Start Date:	July 2011
Estimated Study Completion Date:	July 2012

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.

Eligibility

Ages Eligible for Study:	up to 80 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

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
Study First Received:	June 23, 2011
Last Updated:	June 24, 2011
Health Authority:	Israel: Ministry of Health

ClinicalTrials.gov processed this record on May 23, 2013

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