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Clinical Trials in Poland / NCT07157475
Recruiting Observational

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

NCT07157475 · tracked via the Priya Life Science Poland tracker
Sponsor
Wroclaw Medical University
Phase
Observational
Started
2025-07-01
Last updated
2026-03-23

Condition(s) studied

Peripheral Arterial Disease(PAD)

Investigational drug(s) / intervention(s)

Treatment with SGLT2 inhibitors (flozins)

Treatment with SGLT2 inhibitors (flozins): Patients received SGLT2 inhibitors (empagliflozin, dapagliflozin, canagliflozin) as part of their routine clinical care during the 12-month follow-up period after elective or urgent lower limb revascularization procedures. The study does not assign treatment; medication use occurred independently of the study protocol.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events)-Number of Participants Experiencing MACEor MALE — 12 months from the vascular intervention
    MACE is defined as a composite of : Non-fatal myocardial infarction (MI); Non-fatal stroke involving the central nervous system (CNS); or Cardiovascular death MALE is defined as a composite of : Untreated loss or deterioration of patency in a previously revascularized vessel; Repeat intervention in a revascularized segment due to impaired patency, or Amputation (above or below the knee) of the revascularized limb Unit of Measure: Number of participants with at least one event

Trial sites (1)

FacilityCityRegionStatus
Wroclaw Medical University Wroclaw Lower Silesian Voivodeship Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07157475 on ClinicalTrials.gov ↗ ← All trials in Poland