Clinical trial • Phase III • Cardiology

IOPAMIDOL for Peripheral arterial disease

Phase III trial of IOPAMIDOL for Peripheral arterial disease.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Peripheral arterial disease
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
10-07-2024
First CTIS Authorization Date
25-10-2024

Trial design

Randomised, open-label, control arm: iodinated contrast medium (standard of care) — choice of licensed iodinated contrast agents (examples listed in the application include imeron, solutrast, optiray, accupaque, ultravist, visipaque, jopamiro). dose/schedule: not specified. intervention arm: automated co2 injection (contrast-sparing strategy). dose/schedule: not specified. Phase III trial in Austria, Germany.

Randomised
Yes
Open Label
Yes
Comparator
Control arm: iodinated contrast medium (standard of care) — choice of licensed iodinated contrast agents (examples listed in the application include Imeron, Solutrast, Optiray, Accupaque, Ultravist, Visipaque, Jopamiro). Dose/schedule: Not specified. Intervention arm: automated CO2 injection (contrast-sparing strategy). Dose/schedule: Not specified.
Target Sample Size
1960
Trial Duration For Participant
365

Eligibility

Recruits 1960 No vulnerable populations selected. All participants are adults (Age 18 years or older). Written informed consent is required; subject information and informed consent forms are provided (country-specific ICFs for Austria and Germany)..

Pregnancy Exclusion
Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) until day 30 after PVI.; Pregnant or nursing women
Vulnerable Population
No vulnerable populations selected. All participants are adults (Age 18 years or older). Written informed consent is required; subject information and informed consent forms are provided (country-specific ICFs for Austria and Germany).

Inclusion criteria

  • {"criterion_text":"- Symptomatic peripheral arterial disease presenting with either acute symptoms (Rutherford clinical categories I-IIb) or chronic symptoms (Fontaine stages IIb-IV or Rutherford clinical categories 2-6)\n- Planned peripheral vascular intervention of infrainguinal arteries due to femoropopliteal and/or infrapopliteal lesions\n- Increased risk of CA-AKI identified by a baseline risk score of ≥ 5 points based on a published dedicated PVI risk score [1] and a pre-angiographic estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m²\n- Both angiographic strategies seem feasible at the investigator’s discretion\n- Age 18 years or older\n- Written informed consent"}

Exclusion criteria

  • {"criterion_text":"- Very agitated patients\n- Patients with planned full anaesthesia during procedure\n- Patients with a life-expectancy less than one year\n- Patients confined to bed that are completely non-ambulatory\n- Known acute renal failure or known unstable renal function as evidenced by a recent increase in serum creatinine (SCr) of > 0.5 mg/dl or > 25% within 7 days\n- Iodinated contrast medium exposure within 7 days prior to procedure with change in SCr ≥ 0.1 mg/dl on two SCr measures ≥ 24 h apart\n- Advanced chronic kidney disease (CKD) with an eGFR < 30 ml/min/1.73 m² and/or dialysis\n- Current use of nephrotoxic agents (aminoglycoside antibiotics, sulfonamides, amphotericin B, or pentamidine), or an active chemotherapy agent\n- Acute or chronic pulmonary disease requiring oxygen therapy\n- Patients with known patent foramen ovale or atrial septal defect\n- Patients with planned nitrous oxide anaesthesia during intervention\n- Patients with manifest hyperthyroidism or manifest thyrotoxicosis\n- Known allergies or hypersensitivity to iodinated contrast media that cannot be adequately pre-treated prior to index procedure\n- Planned further procedure with a need for > 10 ml of iodinated contrast medium (CM) in any location (e.g., CT scan, coronary angiography) within a period of 90 days\n- Any surgical procedure (except minor amputations) or intervention performed within 30 days prior to or planned within 90 days post index procedure\n- Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) until day 30 after PVI.\n- Participation in other interventional trials. (Exceptions are described in the trial protocol)\n- Suspected lack of compliance\n- Pregnant or nursing women"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Major Adverse Kidney Events up to day 90 after intervention (MAKE90)","definition_or_measurement_approach":"MAKE90 assessed up to 90 days after intervention (primary endpoint as stated). Specific component definitions not detailed in the CTIS summary."}

Secondary endpoints

  • {"endpoint_text":"- Main Secondary Endpoint: Post-procedural acute kidney injury (AKI)\n- Major Adverse Kidney Events (MAKE) endpoint up to day 7 (MAKE-7)\n- Single components of MAKE90\n- Major Adverse Kidney Events at 90 days considering a drop in eGFR by at least 40% (instead of 25% as for the primary endpoint) as compared to baseline\n- Technical success\n- Procedural success","definition_or_measurement_approach":"Post-procedural AKI and MAKE-7 measured at specified timepoints (post-procedure, day 7); one secondary endpoint is MAKE90 using an alternative drop in eGFR threshold (≥40% vs primary 25%). Detailed measurement criteria not fully specified in the CTIS summary."}

Recruitment

Planned Sample Size
1960
Recruitment Window Months
54
Consent Approach
Written informed consent obtained from each participant. Country-specific subject information and informed consent forms are available (documents listed for Austria and Germany). Participants are adults (≥18 years) so no assent procedures are required.

Geography

Total Number Of Sites
13
Total Number Of Participants
1960

Austria

Earliest CTIS Part Ii Submission Date
22-10-2024
Latest Decision Or Authorization Date
06-11-2025
Processing Time Days
380
Number Of Sites
2
Number Of Participants
392

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Angiology
Contact Person Name
Oliver Schlager
Contact Person Email
angiologie@meduniwien.ac.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
Department of Radiology
Contact Person Name
Alexander Loizides
Contact Person Email
alexander.loizides@i-med.ac.at

Germany

Earliest CTIS Part Ii Submission Date
29-08-2024
Latest Decision Or Authorization Date
29-10-2025
Processing Time Days
426
Number Of Sites
11
Number Of Participants
1568

Sites

Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie
Contact Person Name
Daniela Branzan
Contact Person Email
daniela.branzan@mri.tum.de
Site Name
MVZ CCB Frankfurt Und Main-Taunus GbR
Department Name
Gefaess Centrum
Contact Person Name
Michael Piorkowski
Contact Person Email
m.piorkowski@ccb.de
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinik für Thorax- und Gefäßchirurgie
Contact Person Name
Sven Seifert
Contact Person Email
sven.seifert@skc.de
Site Name
GRN Gesundheitszentren Rhein-Neckar gGmbH
Department Name
Abteilung Innere Meidzin: Kardiologie und Angiologie
Contact Person Name
Grigorios Korosoglou
Contact Person Email
grigorios.korosoglou@grn.de
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Klinik und Poliklinik für Angiologie
Contact Person Name
Tim Wittig
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Klinik für Angiologie
Contact Person Name
Nadjib Schahab
Contact Person Email
nadjib.schahab@ukbonn.de
Site Name
Evangelisches Krankenhaus Konigin Elisabeth Herzberge gGmbH
Department Name
Gefäßzentrum
Contact Person Name
Karl Julius Büchner
Contact Person Email
h.kublik@keh-berlin.de
Site Name
DIAKO Krankenhaus gGmbH
Department Name
Diagnostische und Interventionelle Radiologie Neuroradiologie
Contact Person Name
Stefan Mueller-Huelsbeck
Site Name
Kreiskrankenhaus des Vogelsbergkreises in Alsfeld GmbH
Department Name
Gefäßchirurgie
Contact Person Name
André Schneider
Contact Person Email
an.schneider@kkh-alsfeld.de
Site Name
SANA Kliniken Oberfranken Coburg GmbH
Department Name
Klinik für Gefäßmedizin
Contact Person Name
Marcus Thieme
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Kardiologie und Angiologie
Contact Person Name
Thomas Zeller

Sponsor

Primary sponsor

Full Name
Universitaet Leipzig
Organisation Type
Educational Institution
Country Of Registered Address
Germany

Third parties

  • {"country":"","full_name":"German Research Foundation (Deutsche Forschungsgemeinschaft, DFG)","duties_or_roles":"Source of monetary support / Funding","organisation_type":""}

Investigational products

Investigational Product Name
Solutrast 370, 370 mg Iod/ml, Injektionslösung
Active Substance
IOPAMIDOL
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION, IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
4.1 millilitre(s)/kilogram
Investigational Product Name
Optiray 320 mg Iod/ml Injektionslösung/Infusionslösung
Active Substance
IOVERSOL
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION, IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
250 ml millilitre(s)
Investigational Product Name
Solutrast 250, 250 mg Iod/ml, Injektionslösung
Active Substance
IOPAMIDOL
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION, IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
6 millilitre(s)/kilogram
Investigational Product Name
VISIPAQUETM 270 mg/ml Injektionslösung
Active Substance
IODIXANOL
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION, IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
7.41 millilitre(s)/kilogram
Investigational Product Name
Imeron 400, 400 mg Iod/ml, Injektionslösung, Infusionslösung
Active Substance
IOMEPROL
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION, IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
250 ml millilitre(s)
Investigational Product Name
Ultravist®-300, 300 mg Iod/ml, Injektions- oder Infusionslösung oder Lösung zum Einnehmen
Active Substance
IOPROMIDE
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION, IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
150 ml millilitre(s)
Investigational Product Name
ACCUPAQUE™ 240 Injektionslösung
Active Substance
IOHEXOL
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION, IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
6.25 millilitre(s)/kilogram
Investigational Product Name
ACCUPAQUE™ 300 Injektionslösung oder Lösung zum Einnehmen
Active Substance
IOHEXOL
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION, IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
5 millilitre(s)/kilogram
Investigational Product Name
Imeron 300, 300 mg Iod/ml, Injektionslösung, Infusionslösung
Active Substance
IOMEPROL
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION, IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
250 ml millilitre(s)
Investigational Product Name
VISIPAQUETM 320 mg/ml Injektionslösung
Active Substance
IODIXANOL
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION, IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
6.25 millilitre(s)/kilogram
Investigational Product Name
Imeron 350, 350 mg Iod/ml, Injektionslösung, Infusionslösung
Active Substance
IOMEPROL
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION, IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
250 ml millilitre(s)
Investigational Product Name
Ultravist®-240, 240 mg Iod/ml, Injektions- oder Infusionslösung
Active Substance
IOPROMIDE
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION, IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
6.25 millilitre(s)/kilogram
Investigational Product Name
ACCUPAQUE™ 350 Injektionslösung oder Lösung zum Einnehmen
Active Substance
IOHEXOL
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION, IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
4.3 millilitre(s)/kilogram
Investigational Product Name
Solutrast 200, 200 mg Iod/ml, Injektionslösung
Active Substance
IOPAMIDOL
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION, IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
7.5 millilitre(s)/kilogram
Investigational Product Name
Solutrast 300, 300 mg Iod/ml, Injektionslösung
Active Substance
IOPAMIDOL
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION, IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
5 millilitre(s)/kilogram
Investigational Product Name
Jopamiro 370 mg J/ml - Stechampullen
Active Substance
IOPAMIDOL
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION, IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
50 ml millilitre(s)
Investigational Product Name
Ultravist®-370, 370 mg Iod/ml, Injektions- oder Infusionslösung oder Lösung zum Einnehmen
Active Substance
IOPROMIDE
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION, IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
4 millilitre(s)/kilogram

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