Impact of Aorto-Iliac Occlusive Disease Treatment on Blood Pressure

NCT07070583 | Not Yet Recruiting

• 1 other identifier: Blood pressure in AIOD
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aorto Iliac Occlusive Disease; Blood Pressure

Outcome Measures

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.

  12 months

Secondary Outcomes (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.

  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

Study Arms (1)

Stent placement

OTHER

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

Procedure: Stent placement

Interventions

Stent placement PROCEDURE

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

Stent placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead

Central Study Contacts

Michel Reijnen, prof.dr.

CONTACT

0031 88 005 7282; vascularsurgery@rijnstate.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 17, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 6, 2026

Record last verified: 2026-01