Aortic Isthmus StenosisISTHANCT05903586
Vascular Changes in Patients With Aotic Isthmus Stenosis After Interventional Therapy
An observational study of Aortic Isthmus Stenosis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Aortic Isthmus Stenosis
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2021to 1 May 2025
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 99 years
- All sexes
- Child, Adult, Older adult
Study population: Patients with Recoarctatio Aortae and planned interventional therapy (balloon dilatation or stent implantation)
Who may be able to join
- male and female persons with Recoarctatio Aortae and planned interventional therapy (balloon dilatation or stent implantation)
- adequate contraceptive methods in females with childbearing potential
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinical Research Center, Department of Nephrology and Hypertension, University Hospital Erlangen
Erlangen, 91054
About this study
Official title: 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).
Read the 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.
- Conditions
- Aortic Isthmus Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (10)
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
Measured: 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
Measured: 4 weeks
change in augmentation index (-) measured using pulse wave analysis
change in augmentation index (-) between baseline and 4 weeks post intervention
Measured: 4 weeks
change in pulse wave velocity (m/s)
change in pulse wave velocity (m/s) between baseline and 4 weeks post intervention
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 4 weeks
change in flow dependent vasodilation measured using the Unex Device
change in flow dependent vasodilation between baseline and 4 weeks post intervention
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Feb 2021
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Isthmus StenosisStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Bosch, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903586
- Sponsor's protocol ID
- ISTHA
- Acronym
- ISTHA
- Status last verified
- Jun 2025
- First submitted
- 6 Jun 2023
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Changes in Patients With Aotic Isthmus Stenosis After Interventional Therapy Using Ballon Angioplasty or Stent Implantation
- ClinicalTrials.gov ID
- NCT05903586
- Acronym / sponsor ID
- ISTHA / ISTHA
- Conditions
- Aortic Isthmus Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Recoarctatio Aortae and planned interventional therapy (balloon dilatation or stent implantation)
Key inclusion criteria (2 listed)
- male and female persons with Recoarctatio Aortae and planned interventional therapy (balloon dilatation or stent implantation)
- adequate contraceptive methods in females with childbearing potential
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 secondary outcomes
change in central diastolic blood pressure (BP) (mmHg) measured using pulse wave analysis
Time frame: 4 weeks
change in central pulse pressure measured (mmHg) using pulse wave analysis
Time frame: 4 weeks
change in augmentation index (-) measured using pulse wave analysis
Time frame: 4 weeks
change in pulse wave velocity (m/s)
Time frame: 4 weeks
change in systolic and diastolic office BP (mmHg)
Time frame: 4 weeks
change in systolic and diastolic 24 hour ambulatory BP (mmHg)
Time frame: 4 weeks
change in retinal arteriolar wall to lumen ratio (-) measured using Scanning Laser Doppler Flowmetry
Time frame: 4 weeks
change in retinal capillary flow (AU) measured using Scanning Laser Doppler Flowmetry
Time frame: 4 weeks
change in retinal capillary density measured using Scanning Laser Doppler Flowmetry
Time frame: 4 weeks
change in flow dependent vasodilation measured using the Unex Device
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Isthmus Stenosis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in central systolic blood pressure (BP) (mmHg) measured using pulse wave analysis (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.