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NCT Number: NCT07070583

Impact of Aorto-Iliac Occlusive Disease Treatment on Blood Pressure

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.

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Key information

Conditions

Aorto Iliac Occlusive Disease Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate

Arnhem, 6815AD, Netherlands

Location status: Recruiting

Location contact

Michel Reijnen, prof

CONTACT

[email protected]

0880057282

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stent placement

Procedure

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Michel Reijnen, prof.dr.

CONTACT

[email protected]

0031 88 005 7282

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2025
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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