ClinicalTrials.gg
RecruitingNCT07070583Updated Apr 3, 2026

Impact of Aorto-Iliac Occlusive Disease Treatment on Blood Pressure

An interventional study of Stent placement in Aorto Iliac Occlusive Disease and Blood Pressure, sponsored by Rijnstate Hospital. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by Rijnstate Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Aorto Iliac Occlusive Disease
  • Blood Pressure
03

In context

Lead sponsor

Rijnstate Hospital is the lead sponsor of 130 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years
  • Singed
  • 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Stent placement

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

    Procedure: Stent placement

Interventions

  • ProcedureStent placement

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Undecided yet

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2026 (actual). Primary completion is estimated for Dec 2027, 21 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 30, 2025
First posted
Jul 17, 2025
StartActual
Mar 30, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Apr 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07070583
Lead sponsor
Rijnstate Hospital
Responsible party
Sponsor
First posted
Jul 17, 2025
Start date
Mar 30, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Apr 3, 2026

Study contacts

Michel Reijnen, prof.dr.
Contact
vascularsurgery@rijnstate.nl
0031 88 005 7282

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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