Vascular Changes in Patients With Aotic Isthmus Stenosis After Interventional Therapy (ISTHA)

Vascular Changes in Patients With Aotic Isthmus Stenosis After Interventional Therapy Using Ballon Angioplasty or Stent Implantation

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).

Study Overview

• Status: Completed
• Conditions: Aortic Isthmus Stenosis

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 Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • Clinical Research Center, Department of Nephrology and Hypertension, University Hospital Erlangen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with Recoarctatio Aortae and planned interventional therapy (balloon dilatation or stent implantation)

Description

Inclusion Criteria:

• male and female persons with Recoarctatio Aortae and planned interventional therapy (balloon dilatation or stent implantation)
• adequate contraceptive methods in females with childbearing potential

Exclusion Criteria:

• other secondary causes for hypertension
• treatment resistent arterial hypertension or uncontrolled hypertension (office BP ≥ 180/110 mmHg)
• history of hypertensive enzephalopathy or intracerebral bleeding
• diabetes mellitus
• cataract
• known renal, respiratory, hepatic, gastrointestinal, endocrine, metabolic, immunolic, hematologic, oncologic, neurologic or psychiatric diseases besides the diagnosis of artoic isthmus stenosis
• one of the following diseases or conditions during the last 6 months: myocardial infaction, instable angina pectoris, cardiac insufficiency
• pregnant or lactating woman or inadequate contraception (pearl-index ≥ 1%)
• participation in another clinical study
• drug or medication abuse
• inadequate adherence or other condition preventing the patient from study participation (in the eyes of the treating physician)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in central systolic blood pressure (BP) (mmHg) measured using pulse wave analysis	change in central systolic blood pressure (BP) (mmHg) between baseline and 4 weeks post intervention	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in central diastolic blood pressure (BP) (mmHg) measured using pulse wave analysis	change in central diastolic blood pressure (BP) (mmHg) between baseline and 4 weeks post intervention	4 weeks
change in central pulse pressure measured (mmHg) using pulse wave analysis	change in central pulse pressure (mmHg) between baseline and 4 weeks post intervention	4 weeks
change in augmentation index (-) measured using pulse wave analysis	change in augmentation index (-) between baseline and 4 weeks post intervention	4 weeks
change in pulse wave velocity (m/s)	change in pulse wave velocity (m/s) between baseline and 4 weeks post intervention	4 weeks
change in systolic and diastolic office BP (mmHg)	change in systolic and diastolic office BP (mmHg) between baseline and 4 weeks post intervention	4 weeks
change in systolic and diastolic 24 hour ambulatory BP (mmHg)	change in systolic and diastolic 24 hour ambulatory BP (mmHg) between baseline and 4 weeks post intervention	4 weeks
change in retinal arteriolar wall to lumen ratio (-) measured using Scanning Laser Doppler Flowmetry	change in retinal arteriolar wall to lumen ratio between baseline and 4 weeks post intervention	4 weeks
change in retinal capillary flow (AU) measured using Scanning Laser Doppler Flowmetry	change in retinal capillary flow (AU) between baseline and 4 weeks post intervention	4 weeks
change in retinal capillary density measured using Scanning Laser Doppler Flowmetry	change in retinal capillary density between baseline and 4 weeks post intervention	4 weeks
change in flow dependent vasodilation measured using the Unex Device	change in flow dependent vasodilation between baseline and 4 weeks post intervention	4 weeks

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: ISTHA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No