Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05903586
Status:
RECRUITING
Last Update Posted:
2023-08-01
First Post:
2023-06-06
Brief Title:
Vascular Changes in Patients With Aotic Isthmus Stenosis After Interventional Therapy
Sponsor:
University of Erlangen-Nürnberg Medical School
Organization:
University of Erlangen-Nürnberg Medical School
Study Overview
Official Title:
Vascular Changes in Patients With Aotic Isthmus Stenosis After Interventional Therapy Using Ballon Angioplasty or Stent Implantation
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISTHA
Brief Summary:
This controlled clinical study investigates arterial blood pressure and vascular remodling before and 4 weeks after catheter interventional treatment of re-stenosis of the aortic isthmus Recoarctatio Aortae
Detailed Description:
Patients with treated aortic isthmus stenosis during their first year of life often develop a Recoarctatio Aortae re-stenosis of the aortic isthmus in the long term followed by arterial hypertension The Recoarctatio Aortae can be treated during a cather intervention by balloon dilatation or stent implantation Patients with arterial hypertension often develop vascular remodeling with increased central systolic blood pressure and increased pulse pressure Vascular remodling predics cardiovascular events and increases mortality Vascular remodeling can be assessed non-invasively by using scanning laser doppler flowmetry SLDF pulse wave analysis and measurement of flow-dependent vasodilation In this controlled clinical study we investigate arterial blood pressure and vascular remodling before and 4 weeks after catheter interventional treatment of Recoarctatio Aortae
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None