Using ultra-low dose contrast for endovascular procedures in patients with kidney issues
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
This study is testing if using very low doses of a special dye during leg procedures is safe for people with kidney problems who aren't on dialysis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Sex | All |
| Sponsor | Attikon Hospital Academic / other |
| Locations | 1 site (Chaidari, Attiki) |
| Trial ID | NCT06835127 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and feasibility of administering ultra-low doses of iodinated contrast agents during infrainguinal endovascular revascularization procedures in patients suffering from chronic limb-threatening ischemia and renal impairment. The study will involve patients who are not on dialysis and have an estimated glomerular filtration rate (eGFR) of less than 60 ml/minute/1.73m2. Procedures will be conducted using a specialized angiography suite, with a focus on minimizing contrast use while ensuring effective treatment. The study will follow a strict hydration protocol before and after the procedures to enhance patient safety.
Who should consider this trial
Good fit: Ideal candidates are patients with chronic limb-threatening ischemia and renal disease stages 2-4 who are scheduled for infrainguinal revascularization procedures.
Not a fit: Patients with end-stage renal disease on dialysis or those with an eGFR greater than 60 ml/minute/1.73m2 will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of acute kidney injury in patients undergoing endovascular procedures.
How similar studies have performed: While the use of low-dose contrast in similar procedures has been explored, this specific approach focusing on ultra-low doses in patients with renal impairment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chaidari, Attiki
- "ATTIKON" University General Hospital, , 1st Rimini St, — Chaidari, Attiki, Greece (Recruiting)
Study contacts
- Principal investigator: Stavros C Spiliopoulos, MD, PhD — ATTIKO University Hospital
- Study coordinator: Stavros C Spiliopoulos, MD, PhD
- Email: stavspiliop@med.uoa.gr
- Phone: +302105831810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.