Skip to main content
OpenTrials
Completed

NCT Number: NCT06835127

Ultra-low Dose Contrast for Endovascular Procedures

The purpose of this protocol is to study the safety and feasibility of using ultra-low dose iodinated contrast agent for infrainguinal endovascular revascularization procedures in patients with chronic limb-threatening lower limb ischemia (CLTI) and impaired renal function, in the new angiography suite of our department.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Impairment Acute Kidney Injury Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Ischemia Kidney Diseases Limb Ischemia, Critical Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

"ATTIKON" University General Hospital, , 1st Rimini St,

Chaïdári, Attica, 12461, Greece

About this study

Prospective, single-center observational study of patients with CLTI and renal failure but not on dialysis (eGFR <60ml/minute/1.73m2, renal disease stages 2-4), who are scheduled to undergo endovascular revascularization procedures of the lower limb arteries. The procedures will be performed on the new angiograph of the interventional radiology unit (Philips Azurion 7 b20/15 biplane) and the contrast administration protocol will include 1:9 or 2:9 dilutions of iso-osmotic iodinated contrast agent (Visipaque 320mg/ml) with saline, with the aim of administering the minimum possible amount for the safe and effective performance of the procedure (As Low As Possible; ALARA).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • CLTI
  • Prescheduled infrainguinal revascularization procedure
  • Renal disease stage 2-4 (eGFR <60ml/minute/1.73m2)
  • Adequate pre- and post-procedural hydration protocol

Exclusion criteria

  • Inadequate pre- and post-procedural hydration protocol
  • End-stage renal disease/ dialysis
  • eGFR >60ml/minute/1.73m2)
  • Endovascular treatment of Iliac artery steno-oclussive disease
  • Allergy to contrast media

Treatment and study plan

Infrainguinal peripheral endovascular revascularization

Procedure

Percutaneous endovascular angioplasty and/or stenting of infrainguinal arteries (femoropopliteal and/or infrapopliteal arteries) under local anesthesia and adjunct mild conscious sedation.

Primary outcomes

  1. Renal function

    Time frame: From the end of the procedure to day 2

    Assessment of eGFR

  2. Technical success

    Time frame: Day 1

    Successful, uneventful revascularization using less than 15 ml of iodinated contrast media.

Secondary outcomes

  1. Renal function

    Time frame: 1 month

    Introduction in dialysis

  2. Limb salvage

    Time frame: 6 months

    Non pre-scheduled above the knee amputation

  3. Survival

    Time frame: 6 months

    Patients' survival rate

  4. Re-intervention

    Time frame: 6 months

    Target lesion reintervention (TLR) due to clinical deterioration or relapse of symptoms

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Official study title

Feasibility Study of the Use of Ultra-low Dose Iodinated Contrast Agent for Endovascular Procedures in Patients With Chronic Limb-threatening Ischemia and Renal Impairment

Acronym: ULTRA-LOW

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2025
Registry last updated
Mar 10, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.