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Back to Peripheral Arterial Disease
Phase 3 Peripheral Arterial Disease Trial, Recruiting
NCT06656988
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have peripheral arterial disease (reduced blood flow in the legs) with either sudden or long-standing symptoms affecting their ability to walk or causing leg pain, wounds, or tissue damage
- People who are scheduled to have a procedure to open up or treat blocked arteries in the leg, below the groin
- People whose kidneys are not working at full capacity (a specific kidney function test score below a set level) and who have a higher-than-average risk of kidney damage from the dye used during the procedure, based on a published scoring system
- People where the trial site doctor considers both types of imaging approaches being studied to be medically suitable
- People aged 18 years or older
- People who have given written consent to participate
Who may not be able to join:
- People who are very agitated or unsettled
- People who are planned to be under full general anaesthesia during the procedure
- People whose life expectancy is less than one year
- People who are completely confined to bed and unable to walk at all
- People with known sudden kidney failure, or unstable kidney function shown by a significant rise in a specific kidney marker in blood tests within the past 7 days
- People who have had contrast dye (used in imaging) within the past 7 days and whose kidney blood test results have changed in a specific way since then
- People with advanced chronic kidney disease (a kidney function level below a certain threshold) or who are already on dialysis
- People currently taking certain medications that can harm the kidneys, including some antibiotics (aminoglycosides, sulfonamides, amphotericin B, or pentamidine) or active cancer chemotherapy
- People with a lung condition that requires them to use oxygen therapy
- People known to have certain heart structural conditions (a hole between the upper chambers of the heart)
- People planned to receive a specific type of anaesthetic gas (nitrous oxide) during the procedure
- People with an overactive thyroid gland that is causing symptoms
- People with a known allergy or sensitivity to the contrast dye used in imaging that cannot be adequately treated beforehand
- People with severely uncontrolled heart failure
- People with a condition causing abnormal muscle spasms related to low calcium levels (tetany)
- People who are expected to need more than 10 ml of contrast dye for any other medical procedure (such as a CT scan or heart imaging) within 90 days of this procedure
- People who have had a major surgical procedure or intervention in the 30 days before, or who have one planned within 90 days after, the trial procedure (minor amputations may be an exception)
- Women who could become pregnant and are not using an approved form of contraception up until 30 days after the procedure
- People already taking part in other interventional clinical trials (some exceptions may apply — confirm with trial site)
- People where there are concerns about their ability to follow the trial requirements
- Women who are pregnant or breastfeeding
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Sabine Steiner, Prof Dr, University Leipzig
Phone: +493419718770
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Recruiting
Phase
Phase 3
Sponsor
University of Leipzig
Registry
ClinicalTrials.gov
Start date
14 April 2025
Est. completion
1 February 2028
Where this trial is recruiting
🇦🇹 Austria
🇩🇪 Germany
Primary endpoints
MAKE 90
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.