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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function | Introduction in dialysis | 1 month |
| Limb salvage | Non pre-scheduled above the knee amputation | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suffering from renal impairment stage 2 to 4 and chronic -limb-threatening ischemia (CLTI)
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| Name | Affiliation | Role |
|---|---|---|
| Stavros C Spiliopoulos, MD, PhD | ATTIKO University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "ATTIKON" University General Hospital, , 1st Rimini St, | Chaïdári | Attica | 12461 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31182334 | Background | 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. | |
| 29426991 |
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All study data will be available upon reasonable request
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D000089802 | Chronic Limb-Threatening Ischemia |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Survival | Patients' survival rate | 6 months |
| Re-intervention | Target lesion reintervention (TLR) due to clinical deterioration or relapse of symptoms | 6 months |
| 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. |
| 26630997 | 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |