Renal ImpairmentULTRA-LOWNCT06835127
Ultra-low Dose Contrast for Endovascular Procedures
An observational study of Renal Impairment and Limb Ischemia, Critical, run by Attikon Hospital at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Impairment, Limb Ischemia, Critical
- What is being tested?
- Infrainguinal peripheral endovascular revascularization
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2024to 23 Jan 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suffering from renal impairment stage 2 to 4 and chronic -limb-threatening ischemia (CLTI)
Who may be able to join
- CLTI
- Prescheduled infrainguinal revascularization procedure
- Renal disease stage 2-4 (eGFR <60ml/minute/1.73m2)
- Adequate pre- and post-procedural hydration protocol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
"ATTIKON" University General Hospital, , 1st Rimini St,
Chaïdári, Attica, 12461
About this study
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
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.
Read the 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).
- Conditions
- Renal Impairment, Limb Ischemia, Critical
- Being tested
- Infrainguinal peripheral endovascular revascularization
- Keywords
- Endovascular procedures, Angioplasty, Stenting, Acute kidney injury
- Medical subject headings
- Renal Insufficiency, Chronic Limb-Threatening Ischemia, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrainguinal peripheral endovascular revascularizationProcedure or surgery
Percutaneous endovascular angioplasty and/or stenting of infrainguinal arteries (femoropopliteal and/or infrapopliteal arteries) under local anesthesia and adjunct mild conscious sedation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Infrainguinal peripheral endovascular revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function
Assessment of eGFR
Measured: From the end of the procedure to day 2
Technical success
Successful, uneventful revascularization using less than 15 ml of iodinated contrast media.
Measured: Day 1
Secondary outcomes (4)
Renal function
Introduction in dialysis
Measured: 1 month
Limb salvage
Non pre-scheduled above the knee amputation
Measured: 6 months
Survival
Patients' survival rate
Measured: 6 months
Re-intervention
Target lesion reintervention (TLR) due to clinical deterioration or relapse of symptoms
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Sep 2024
- Primary completion23 Jan 2026
- Study completion23 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stavros Spiliopoulos, Attikon Hospital
- Investigators
- Stavros C Spiliopoulos, MD, PhD, Principal investigator, ATTIKO University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835127
- Sponsor's protocol ID
- ABD126
- Acronym
- ULTRA-LOW
- Status last verified
- Mar 2026
- First submitted
- 12 Feb 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All study data will be available upon reasonable request
Publications
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.
PubMed 31182334van 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.
PubMed 29426991Jens 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.
PubMed 26630997
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06835127
- Acronym / sponsor ID
- ULTRA-LOW / ABD126
- Conditions
- Renal Impairment, Limb Ischemia, Critical
- Keywords
- Endovascular procedures, Angioplasty, Stenting, Acute kidney injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Procedure: Infrainguinal peripheral endovascular revascularizationPatients with renal disease stages 2-4, scheduled to undergo infrainguinal endovascular procedures due to CLTI, using ultra-low dose of iodine contrast media. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suffering from renal impairment stage 2 to 4 and chronic -limb-threatening ischemia (CLTI)
Key inclusion criteria (4 listed)
- CLTI
- Prescheduled infrainguinal revascularization procedure
- Renal disease stage 2-4 (eGFR <60ml/minute/1.73m2)
- Adequate pre- and post-procedural hydration protocol
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrainguinal peripheral endovascular revascularizationPercutaneous endovascular angioplasty and/or stenting of infrainguinal arteries (femoropopliteal and/or infrapopliteal arteries) under local anesthesia and adjunct mild conscious sedation. | Procedure or surgery | Study cohort |
Primary outcome
Renal function
Time frame: From the end of the procedure to day 2
Assessment of eGFR
Technical success
Time frame: Day 1
Successful, uneventful revascularization using less than 15 ml of iodinated contrast media.
4 secondary outcomes
Renal function
Time frame: 1 month
Limb salvage
Time frame: 6 months
Survival
Time frame: 6 months
Re-intervention
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 31182334Conte 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.
- Background: PubMed 29426991van 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.
- Background: PubMed 26630997Jens 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.
- Individual participant dataSharing planned: Undecided. All study data will be available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stavros C Spiliopoulos, MD, PhD principal investigator
ATTIKO University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Impairment and Limb Ischemia, Critical, run by Attikon Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function (time frame: From the end of the procedure to day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06835127, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.