Vascular Changes in Patients With Aotic Isthmus Stenosis After Interventional Therapy

Launched by UNIVERSITY OF ERLANGEN-NÜRNBERG MEDICAL SCHOOL · Jun 6, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how blood vessels change in patients with a condition called aortic isthmus stenosis after they receive a specific treatment. The study will measure blood pressure and observe how the arteries develop before and four weeks after patients undergo a procedure to open up the narrowed part of the aorta, which is the main artery in the body. The trial is currently recruiting participants and is open to adults aged 18 to 80 who have this condition and are planning to receive balloon treatment or a stent.

To be eligible for the study, participants must be male or female with a diagnosed aortic isthmus stenosis and should not have other serious health issues, like uncontrolled high blood pressure or diabetes. Women who can become pregnant must also use effective birth control. If you join the trial, you can expect to have your blood pressure monitored and undergo the treatment, with follow-up assessments about your vascular health. This study aims to better understand the effects of the treatment, which could help improve care for future patients with this condition.

Gender

ALL

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)