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Intravascular Stents Fracture Effects

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01382381
First Posted: June 27, 2011
Last Update Posted: June 27, 2011
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.
Information provided by:
Rambam Health Care Campus
  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

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

  Contacts and Locations
No Contacts or Locations Provided
  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 Submitted: June 23, 2011
First Posted: June 27, 2011
Last Update Posted: June 27, 2011
Last Verified: February 2011