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

June 2, 2025 updated by: Agnes Bosch, University of Erlangen-Nürnberg Medical School

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in central systolic blood pressure (BP) (mmHg) measured using pulse wave analysis
Time Frame: 4 weeks
change in central systolic blood pressure (BP) (mmHg) between baseline and 4 weeks post intervention
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in central diastolic blood pressure (BP) (mmHg) measured using pulse wave analysis
Time Frame: 4 weeks
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
Time Frame: 4 weeks
change in central pulse pressure (mmHg) between baseline and 4 weeks post intervention
4 weeks
change in augmentation index (-) measured using pulse wave analysis
Time Frame: 4 weeks
change in augmentation index (-) between baseline and 4 weeks post intervention
4 weeks
change in pulse wave velocity (m/s)
Time Frame: 4 weeks
change in pulse wave velocity (m/s) between baseline and 4 weeks post intervention
4 weeks
change in systolic and diastolic office BP (mmHg)
Time Frame: 4 weeks
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)
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
change in retinal capillary density between baseline and 4 weeks post intervention
4 weeks
change in flow dependent vasodilation measured using the Unex Device
Time Frame: 4 weeks
change in flow dependent vasodilation between baseline and 4 weeks post intervention
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Erlangen-Nürnberg Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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