Vascular Changes in Patients With Aotic Isthmus Stenosis... | NCT05903586

Studies
Vascular Changes in Patients With Aotic Isthmus Stenosis After Interventional Therapy

NCT05903586

Sponsor

University of Erlangen-Nürnberg Medical School

Status

Completed

Last Update Posted

Jun 3, 2025Actual

Enrollment

13Actual

Phase

Not provided

Conditions

Aortic Isthmus Stenosis

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Actual

Primary Completion Date

May 1, 2025Actual

Completion Date

May 1, 2025Actual

First Submitted Date

Jun 6, 2023

First Submission Date that Met QC Criteria

Jun 6, 2023

First Posted Date

Jun 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2025

Last Update Posted Date

Jun 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

99 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Center, Department of Nephrology and Hypertension, University Hospital Erlangen		Erlangen		91054	Germany