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
  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
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.

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 October 23, 2014