Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors

Recruiting now

Conditions studied: Peripheral Arterial Disease(PAD)

In brief

The study is observational and involves patients (pts) with peripheral arterial occlusive disease (PAD) who have undergone lower limb revascularization procedures. Patients who are at least one year post-procedure will be contacted by phone and asked whether any cardiovascular complications occurred during that period, specifically major adverse cardiovascular events (MACE) or major adverse limb events (MALE), and whether they had been taking sodium-glucose co-transporter 2 inhibitors (SGLT2-i, "flozins") during the year following the procedure. The results from the group of pts who, for any reason, received SGLT2-i treatment after the vascular procedure (including those who had initiated treatment before surgery) will be compared to the results from the group of patients who did not receive such treatment, with regard to the occurrence of the aforementioned complications.

Key facts

Study ID

NCT07157475

Run by

Wroclaw Medical University

People needed

300

Starts

2025-07-01

Expected to finish

2026-12-31

Last updated by the study team

2026-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Peripheral vascular procedure ( Conventional surgical procedure or minimally invasive procedure) due to acute or chronic ischemia
• Use of SGLT2 inhibitors (applies only to the group exposed to flozins) for at least 3 months prior to the vascular procedure (the indication for initiating the drug is irrelevant: chronic kidney disease [CKD] / cardiac reasons / diabetes), or immediately after the vascular procedure
• Ability to determine the patient's outcomes within a minimum of 30 days up to 1 year following the vascular procedure

You may not qualify if…

• Vascular injury as the reason for the procedure
• Amputation due to causes other than ischemia (e.g., cancer, neuropathy, trauma without coexisting ischemia)
• Planned revascularization procedure other than for the lower limbs at the time of hospital discharge (e.g., coronary or carotid arteries)
• Planned ischemia-related amputation or reoperation of the operated limb at the time of hospital discharge
• Planned other major surgical procedure with high cardiovascular risk at the time of hospital discharge

Where it is running

• Wroclaw Medical University — Wroclaw, Lower Silesian Voivodeship, Poland (enrolling)

Full record on ClinicalTrials.gov

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