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NCT Number: NCT07157475

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

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.

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Key information

Conditions

Peripheral Arterial Disease(PAD) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, Poland

Location status: Recruiting

Location contact

Edyta Sutkowska, M.D., PH.D.

CONTACT

[email protected]

48503077016

About this study

Project Objective: To assess the impact of SGLT2 inhibitors (SGLT2-i) on vascular complications in patients undergoing peripheral revascularization.

Specific Objective: To evaluate the incidence of 3-point MACE* (Major Adverse Cardiac Events) and MALE** (Major Adverse Limb Events) following vascular surgical procedures (both open and minimally invasive), performed in patients treated with SGLT2- i vs controls ( non-treated pts).

Observation Period: One year - assessment at 30 days, 3 months, and 1 year post-procedure.

Definitions for:

  • MACE = Non-fatal myocardial infarction (MI),Non-fatal stroke involving the central nervous system (CNS), Cardiovascular death

** MALE = Untreated restenosis or deterioration in patency of a previously revascularized vessel , Reintervention in the revascularized segment due to impaired patency, Amputation (either above or below the knee) of the revascularized limb.

Demographic and clinical data will be obtained from the medical records of patients hospitalized in three vascular surgery departments (Wrocław, Poznań, Warsaw), while information regarding MACE , MALE, and the use of SGLT2-i will be collected via telephone interviews with the patients (or their family members, if the patient is deceased).

The number of MACE and MALE incidents during the year following the procedure will be compared between the two groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment with SGLT2 inhibitors (flozins)

Drug

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.

Primary outcomes

  1. MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events)-Number of Participants Experiencing MACEor MALE

    Time frame: 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

Secondary outcomes

  1. Non-fatal Myocardial Infarction (MI)

    Time frame: 12 months from the vascular intervention

    Non-fatal myocardial infarction (MI), Unit of Measure: Number of participants

    Non-fatal stroke involving the central nervous system (CNS)

    Cardiovascular death

    Untreated loss or deterioration of patency in a previously revascularized vessel

    Repeat intervention in a revascularized segment due to impaired patency

    Amputation (above or below the knee) of the revascularized limb

  2. Non-fatal Stroke Involving the Central Nervous System (CNS)

    Time frame: 12 months from the vascular intervention

    Non-fatal Stroke Involving the Central Nervous System (CNS), Unit of Measure: Number of participants

  3. Cardiovascular Death

    Time frame: 12 months from the vascular intervention

    Cardiovascular Death, Unit of Measure: Number of participants

  4. Loss or Deterioration of Patency in a Previously Revascularized Vessel

    Time frame: 12 months from the vascular intervention

    Loss or Deterioration of Patency in a Previously Revascularized Vessel, Unit of Measure: Number of participants

  5. Repeat intervention in a revascularized segment due to impaired patency

    Time frame: 12 months from the vascular intervention

    Repeat intervention in a revascularized segment due to impaired patency; Unit of Measure: Number of participants and number of limbs

  6. Amputation of the revascularized limb

    Time frame: 12 months from the vascular intervention

    Amputation (above or below the knee) of the revascularized limb; Unit of Measure: Number of participants and number of limbs

Other outcomes

  1. Additional secondary endpoint- Surgical site infection (SSI)

    Time frame: 12 months from vascular intervention

    Surgical site infection occurring after the index vascular intervention. Unit of Measure: Number of participants

  2. Additional secondary endpoint- Significant bleeding

    Time frame: 12 months from vascular intervention

    Clinically significant bleeding events as assessed by treating physician (according to established clinical criteria). Unit of Measure: Number of participants

  3. Additional secondary endpoint- Kidney injury

    Time frame: 12 months from vascular intervention

    Acute kidney injury occurring after vascular intervention, defined according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria. Unit of Measure: Number of participants

  4. Additional secondary endpoint- Reintervention in the Same Vascular Segment

    Time frame: 12 months from vascular intervention

    Readmission and repeat procedure in the same vascular segment due to impaired patency. Unit of Measure: Number of participants and number of limbs

  5. Additional secondary endpoint- Foot Necrosis

    Time frame: 12 months from vascular intervention

    Development of necrosis in the treated limb within the study period. Unit of Measure: Number of participants and number of limbs

  6. Additional secondary endpoint- Minor Amputation

    Time frame: 12 months from vascular intervention

    Minor amputation defined as amputation within the foot (below the ankle). Unit of Measure: Number of participants and number of limbs

  7. Additional secondary endpoint- Heart Failure Hospitalization

    Time frame: 12 months from vascular intervention

    Hospital admission with a primary diagnosis of heart failure. Unit of Measure: Number of participants

Study contacts

Contact information is provided by the study sponsor or research team.

Edyta Sutkowska, M.D., Ph.D.

CONTACT

[email protected]

48503077016

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Collaborators

  • Military Institute od Medicine National Research Institute
  • Poznan University of Medical Sciences

Registry information

Official study title

Ocena powikłań Naczyniowych u pacjentów Poddanych Rewaskularyzacji Obwodowej: wpływ inhibitorów SGLT-2 The Assessment of Vascular Complications in Patients Undergoing Peripheral Revascularization: The Impact of SGLT-2 Inhibitors

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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