Ultra-low Dose Contrast for Endovascular Procedures (ULTRA-LOW)

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Impairment; Limb Ischemia, Critical
• Intervention / Treatment: Procedure: Infrainguinal peripheral endovascular revascularization

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Chaïdári, Attica, Greece, 12461
      • "ATTIKON" University General Hospital, , 1st Rimini St,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from renal impairment stage 2 to 4 and chronic -limb-threatening ischemia (CLTI)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study cohort; Patients with renal disease stages 2-4, scheduled to undergo infrainguinal endovascular procedures due to CLTI, using ultra-low dose of iodine contrast media.	Procedure: Infrainguinal peripheral endovascular revascularization; Percutaneous endovascular angioplasty and/or stenting of infrainguinal arteries (femoropopliteal and/or infrapopliteal arteries) under local anesthesia and adjunct mild conscious sedation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal function	Assessment of eGFR	From the end of the procedure to day 2
Technical success	Successful, uneventful revascularization using less than 15 ml of iodinated contrast media.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal function	Introduction in dialysis	1 month
Limb salvage	Non pre-scheduled above the knee amputation	6 months
Survival	Patients' survival rate	6 months
Re-intervention	Target lesion reintervention (TLR) due to clinical deterioration or relapse of symptoms	6 months

Collaborators and Investigators

• Sponsor: Attikon Hospital
• Investigators: Principal Investigator: Stavros C Spiliopoulos, MD, PhD, ATTIKO University Hospital

Publications and helpful links

General Publications

• van der Molen AJ, Reimer P, Dekkers IA, Bongartz G, Bellin MF, Bertolotto M, Clement O, Heinz-Peer G, Stacul F, Webb JAW, Thomsen HS. Post-contrast acute kidney injury - Part 1: Definition, clinical features, incidence, role of contrast medium and risk factors : Recommendations for updated ESUR Contrast Medium Safety Committee guidelines. Eur Radiol. 2018 Jul;28(7):2845-2855. doi: 10.1007/s00330-017-5246-5. Epub 2018 Feb 9.
• Jens S, Schreuder SM, De Boo DW, van Dijk LC, van Overhagen H, Bipat S, Koelemay MJ, Reekers JA. Lowering iodinated contrast concentration in infrainguinal endovascular interventions: a three-armed randomized controlled non-inferiority trial. Eur Radiol. 2016 Aug;26(8):2446-54. doi: 10.1007/s00330-015-4109-1. Epub 2015 Dec 2.
• Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH, Aboyans V, Aksoy M, Alexandrescu VA, Armstrong D, Azuma N, Belch J, Bergoeing M, Bjorck M, Chakfe N, Cheng S, Dawson J, Debus ES, Dueck A, Duval S, Eckstein HH, Ferraresi R, Gambhir R, Gargiulo M, Geraghty P, Goode S, Gray B, Guo W, Gupta PC, Hinchliffe R, Jetty P, Komori K, Lavery L, Liang W, Lookstein R, Menard M, Misra S, Miyata T, Moneta G, Munoa Prado JA, Munoz A, Paolini JE, Patel M, Pomposelli F, Powell R, Robless P, Rogers L, Schanzer A, Schneider P, Taylor S, De Ceniga MV, Veller M, Vermassen F, Wang J, Wang S; GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. 2019 Jul;58(1S):S1-S109.e33. doi: 10.1016/j.ejvs.2019.05.006. Epub 2019 Jun 8.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): January 23, 2026
• Study Completion (Actual): January 23, 2026

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 15, 2025
• First Posted (Actual): February 19, 2025

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Angioplasty; Acute kidney injury; Endovascular procedures; Stenting
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease; Pathological Conditions, Signs and Symptoms; Chronic Limb-Threatening Ischemia; Acute Kidney Injury; Renal Insufficiency
• Other Study ID Numbers: ABD126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: All study data will be available upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No