Investigating vascular changes after treatment for aortic isthmus stenosis
Vascular Changes in Patients With Aotic Isthmus Stenosis After Interventional Therapy Using Ballon Angioplasty or Stent Implantation
This study looks at how blood vessels change in patients who have had treatment for aortic isthmus stenosis to see if a new procedure helps improve their blood pressure and overall vascular health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 16 (estimated) |
| Ages | 12 Years to 99 Years |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Locations | 1 site (Erlangen) |
| Trial ID | NCT05903586 on ClinicalTrials.gov |
What this trial studies
This observational study examines arterial blood pressure and vascular remodeling in patients with Recoarctatio Aortae before and four weeks after catheter interventional treatment. The focus is on patients who have previously undergone treatment for aortic isthmus stenosis and may develop re-stenosis leading to hypertension. Non-invasive methods such as scanning laser doppler flowmetry and pulse wave analysis will be utilized to assess vascular changes. The study aims to understand the long-term effects of interventional therapy on vascular health.
Who should consider this trial
Good fit: Ideal candidates include males and females with Recoarctatio Aortae who are scheduled for interventional therapy.
Not a fit: Patients with secondary causes of hypertension or uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of vascular health in patients with aortic isthmus stenosis and reduce the risk of cardiovascular events.
How similar studies have performed: Other studies have shown success in assessing vascular remodeling in similar patient populations, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Erlangen
- Clinical Research Center, Department of Nephrology and Hypertension, University Hospital Erlangen — Erlangen, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.