Evaluating coronary revascularization in patients with peripheral artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess whether a combination of best medical therapy and selective coronary revascularization, guided by Fractional Flow Reserve derived from CT (FFRct), can reduce adverse cardiac events in patients with symptomatic Peripheral Arterial Disease (PAD) who have recently undergone lower-extremity revascularization. Participants will be randomly assigned to receive either best medical therapy alone or best medical therapy plus coronary CT angiography and FFRct analysis to evaluate coronary lesions. The study will follow patients for up to five years to monitor outcomes and adverse events. An independent committee will review all clinical endpoints to ensure unbiased results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Inform consent obtained before any study-related activities;
2. Age above or equal to 50 years with symptomatic lower extremity PAD (severe claudication or chronic limb-threatening ischemia, Rutherford 3,4,5) which has been successfully revascularized by open surgical or endovascular procedure within the past 14 days;
3. Willing and able to undergo coronary CTA scan within 14 days of randomization and agrees to submission of CTA data set for HeartFlow FFRct analysis with results made available to treating physician.

Exclusion Criteria:

1. Known CAD, history of MI, prior coronary revascularization (PCI or CABG);
2. Patient underwent coronary angiography or coronary CTA before the randomization;
3. Known history of 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome;
4. History of severe asthma, severe or bronchodilator-dependent Chronic obstructive pulmonary disease (COPD);
5. Severe congestive heart failure (NYHA III or IV);
6. Severe arrhythmia, prior pacemaker or internal defibrillator lead implantation;
7. Impaired chronic renal function (EPI-Glomerular Filtration Rate (GFR)\<30ml/min);
8. Subjects with known anaphylactic allergy to iodinated contrast;
9. Pregnancy or unknown pregnancy status in subject of childbearing potential;
10. Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \<90 mmHg, or acute pulmonary edema;
11. Any active, serious, life-threatening disease with a life expectancy of less than 2 years;
12. Any active infection;
13. Inability to comply with study procedures;
14. Contraindication for guideline-guided longterm antiplatelet/anticoagulation regime after PCI/CABG;
15. Participation in any interventional clinical study within 30 days prior to screening.

Where it's running

• Pauls Stradins Clinical University hospital
  Riga, Latvia Recruiting

Study contacts

• Principal investigator: Dainis Krievins, MD, PhD — Institute of Science, Pauls Stradins Clinical University Hospital
• Study coordinator: Dainis Krievins, MD, PhD
• Email: dainis.krievins@gmail.com
• Phone: +371 29450000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.