Impact of Aorto-Iliac Occlusive Disease Treatment on Blood Pressure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stent placement.
- Who it may be relevant to
- Registry conditions: Aorto Iliac Occlusive Disease, Blood Pressure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Impact of Endovascular Treatment of Aorto-iliac Disease on Systemic Hypertension A Pilot Study Impact of Aorto-Iliac Occlusive Disease Treatment on Blood Pressure
Overview
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.
Interventions
- Procedure Stent placement
Patients with an aorto-iliac occlusion will receive a stent, according to standard care
Primary outcome measures
- 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 outcome measures (3)
- 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]
- 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]
- 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]
Eligibility criteria
Inclusion criteria
- 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
- Clinical indication for treatment of the pathology (Chronic limb threatening ischemia or disabling intermittent claudication not responding to supervised exercise training)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Rijnstate — Arnhem
Identifiers
NCT: NCT07070583 · Blood pressure in AIOD