Aorto Iliac Occlusive Disease, Blood Pressure
Conditions
Brief summary
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
PROCEDUREStent placement
Patients with an aorto-iliac occlusion will receive a stent, according to standard care
Sponsors
Rijnstate Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 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. | 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. | 12 months |
Countries
Netherlands
Contacts
CONTACTMichel Reijnen, prof.dr.
Outcome results
None listed