Intravascular Stents Fracture Effects

• Conditions: Durability of Implanted Intravascular Stents; Hemodynamic Effect of Implanted Intravascular Stents

• Registration Number: NCT01382381
• Lead Sponsor: Rambam Health Care Campus

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.

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 Timeline

• Status Verified: 2011-02
• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-24
• Last Update Submitted: 2011-06-24
• Study First Posted: 2011-06-27
• Last Update Posted: 2011-06-27
• Study Start: 2011-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

-Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified