Ultra-low Dose Contrast for Endovascular Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-01-23

Brief Summary

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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.

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Detailed Description

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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

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Renal Impairment Limb Ischemia, Critical

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Infrainguinal peripheral endovascular revascularization

Intervention Type PROCEDURE

Percutaneous endovascular angioplasty and/or stenting of infrainguinal arteries (femoropopliteal and/or infrapopliteal arteries) under local anesthesia and adjunct mild conscious sedation.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No