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A contrast medium sparing strategy using automated Carbon Dioxide Injection during PERIpheral vascular interventions for PREVENTion of Major Adverse Kidney Events (MAKE): the PeriPREVENT randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512876-37-00
Acronym
PeriPREVENT
Enrollment
1960
Registered
2024-10-25
Start date
2025-04-11
Completion date
Unknown
Last updated
2025-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease (PAD)

Brief summary

Major Adverse Kidney Events up to day 90 after intervention (MAKE90)

Detailed description

Main Secondary Endpoint: Post-procedural acute kidney injury (AKI), Major Adverse Kidney Events (MAKE) endpoint up to day 7 (MAKE-7), Single components of MAKE90, 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, Technical success, Procedural success

Interventions

DRUGSolutrast 370
DRUG370 mg Iod/ml
DRUGOptiray 320 mg Iod/ml Injektionslösung/Infusionslösung
DRUGSolutrast 250
DRUG250 mg Iod/ml
DRUGVISIPAQUETM 270 mg/ml Injektionslösung
DRUGImeron 400
DRUG400 mg Iod/ml
DRUGUltravist®-300
DRUG300 mg Iod/ml
DRUGInjektions- oder Infusionslösung oder Lösung zum Einnehmen
DRUGACCUPAQUE™ 240 Injektionslösung
DRUGACCUPAQUE™ 300 Injektionslösung oder Lösung zum Einnehmen
DRUGImeron 300
DRUGVISIPAQUETM 320 mg/ml Injektionslösung
DRUGImeron 350
DRUG350 mg Iod/ml
DRUGUltravist®-240
DRUG240 mg Iod/ml
DRUGInjektions- oder Infusionslösung
DRUGSolutrast 200
DRUG200 mg Iod/ml
DRUGSolutrast 300
DRUGJopamiro 370 mg J/ml - Stechampullen
DRUGUltravist®-370

Sponsors

Universitaet Leipzig
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Major Adverse Kidney Events up to day 90 after intervention (MAKE90)

Secondary

MeasureTime frame
Main Secondary Endpoint: Post-procedural acute kidney injury (AKI), Major Adverse Kidney Events (MAKE) endpoint up to day 7 (MAKE-7), Single components of MAKE90, 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, Technical success, Procedural success

Countries

Austria, Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026