Health TrialsbyHealthPanel

Impact of Aorto-Iliac Occlusive Disease Treatment on Blood Pressure

ConditionsAorto Iliac Occlusive DiseaseBlood Pressure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRijnstate Hospital

About this trial

Hypertension is a major risk factor for a variety of cardiovascular diseases. When hypertension results from increased vascular resistance due to a narrowing of the descending aorta, it can be effectively treated with stenting. More recently, evidence suggest that stenting in more distal parts of the arterial vascular bed is also associated with a reduction in blood pressure. The investigators hypothesize that stenting of occlusions more distal of the descending aorta decreases the central blood pressure and afterload as reflected by NT-proBNP (N-terminal pro-Brain Natriuretic Peptide), a biomarker of intracardiac pressures and predictor of heart failure events. The goal of this pilot study is to prospectively investigate changes in blood pressure after stent placement in the aorto-iliac region.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Singed informed consent

Chronic occlusion in the infrarenal aorta and/or one or both common iliac arteries

Total lesion length of ≥30mm

Disqualifiers

Patient is unable to understand the study requirements and/ or is unwilling to adhere to the follow-up

Juxtarenal pathology (<2cm below the lowest renal artery)

Acute occlusion of the target area (Acute Leriche Syndrome)

Embolic disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Stent placement

    Procedure/Surgery

    Patients with an aorto-iliac occlusion will receive a stent, according to standard care

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Stent placementOther 1 intervention

Trial outcomes

Primary outcomes

1

The primary objective is to describe the changes in arterial blood pressures between baseline and 12 months follow-up after endovascular treatment of an occlusion of the infrarenal aorta and/or common iliac arteries.

Time frame
12 months

Secondary outcomes

1

To gather information about the association between cardiac biomarkers (hemoglobin, creatinin, NT-pro-BNP) on blood pressure at 12 months in patients with treatment for an occlusion of the infrarenal aorta and/or common iliac arteries.

Time frame
12 months
2

To determine if treatment of an occlusion of the infrarenal aorta and/or common iliac arteries will change the Pulse Wave Analysis (PWA) Pulse Wave Velocity (PWV) measurements at 12 months, compared to baseline.

Time frame
12 months
3

To investigate if treatment of an occlusion of the infrarenal aorta and/or common iliac arteries will decrease or increase the number of anti-hypertensive medication use at 12 months, compared to baseline.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rijnstate Hospital

Lead sponsor

Source ClinicalTrials.gov
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