Intravascular Stents Fracture Effects

Durability of Implanted Intravascular Stents Clinical Trial

Official title:

Evaluation of Implanted Aortic Arch and Branch Pulmonary Artery Stents Durability and Function

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01382381
• Other study ID #: 0081CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: June 23, 2011
• Last updated: June 24, 2011
• Start date: July 2011
• Est. completion date: July 2012

Study information

• Verified date: February 2011
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-Pregnancy

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Durability of Implanted Intravascular Stents
• Hemodynamic Effect of Implanted Intravascular Stents

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus