Ultra-low Dose Contrast for Endovascular Procedures

NCT06835127 | Completed

• 1 other identifier: ABD126
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Impairment; Limb Ischemia, Critical

Keywords

Endovascular procedures; Angioplasty; Stenting; Acute kidney injury

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Renal function

  1 month

• Limb salvage

  6 months

• Survival

  6 months

• Re-intervention

  6 months

Study Arms (1)

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

Interventions

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.

Study cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

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

Chaïdári, Attica, 12461, Greece

Location

Related Publications (3)

• 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.

  PMID: 31182334 BACKGROUND

• 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.

  PMID: 29426991 BACKGROUND

• 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.

  PMID: 26630997 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency; Chronic Limb-Threatening Ischemia; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Stavros C Spiliopoulos, MD, PhD

  ATTIKO University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Interventional Radiology

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 19, 2025
• Study Start: September 1, 2024
• Primary Completion: January 23, 2026
• Study Completion: January 23, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

GR (1)