Clinical trial NCT06835127: Ultra-low Dose Contrast for Endovascular Procedures
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Impairment
Limb Ischemia, Critical
Keywords: Endovascular procedures
Angioplasty
Stenting
Acute kidney injury
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from renal impairment stage 2 to 4 and chronic -limb-threatening ischemia (CLTI)

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Renal function
timeFrame: From the end of the procedure to day 2
measure: Technical success
timeFrame: Day 1
Secondary outcomes:
measure: Renal function
timeFrame: 1 month
measure: Limb salvage
timeFrame: 6 months
measure: Survival
timeFrame: 6 months
measure: Re-intervention
timeFrame: 6 months
Other outcomes:
Locations:
city: Chaidari
country: Greece
facility: "ATTIKON" University General Hospital, , 1st Rimini St,
state: Attiki
Study officials:
affiliation: ATTIKO University Hospital
name: Stavros C Spiliopoulos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.