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Transfemoral aortic valve replacement with or without coronary angiogram

Treatment of Severe Aortic Stenosis With Transfemoral TAVI With or Without Coronary Angiogram During Diagnostic Work-up (PURE TAVI)

Not applicable Interventional Rede Optimus Hospitalar SA · NCT06898086

This trial tests whether people with severe aortic stenosis having transfemoral TAVI can safely skip routine coronary angiography before the procedure.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment620 (estimated)
Ages18 Years to 120 Years
SexAll
SponsorRede Optimus Hospitalar SA Research network
Locations23 sites (Graz and 22 other locations)
Trial IDNCT06898086 on ClinicalTrials.gov

What this trial studies

The PURE‑TAVI trial is a multicenter, prospective, randomized, controlled trial enrolling patients with severe aortic stenosis who are candidates for transfemoral transcatheter aortic valve implantation (TAVI). Participants are randomized to a management pathway without routine pre‑procedural invasive coronary angiography versus the usual pathway that includes coronary angiography and revascularization if significant disease is found. The trial uses contemporary balloon‑expandable transcatheter valves designed to allow coronary access after implantation and collects data on procedural complications, contrast‑associated kidney injury, bleeding, vascular events, and clinical outcomes over follow‑up. The aim is to see if omitting routine angiography reduces procedure‑related harm without increasing cardiac events.

Who should consider this trial

Good fit: Adults with severe aortic stenosis who are judged suitable for transfemoral TAVI by a multidisciplinary heart team and who can attend the required follow‑up visits are eligible candidates.

Not a fit: Patients with recent coronary angiography/CABG, prior left main PCI, severe angina (CCS ≥3), left ventricular ejection fraction under 30%, recent myocardial infarction, planned open‑heart surgery, inability to undergo femoral access, or life expectancy under one year are unlikely to benefit from skipping pre‑procedural angiography.

Why it matters

Potential benefit: If successful, the approach could reduce contrast‑related kidney injury, bleeding, vascular complications, and overall procedural burden for many older patients undergoing TAVI.

How similar studies have performed: Observational studies and registry data have suggested that routine pre‑TAVI coronary angiography may be unnecessary in selected patients, but randomized evidence remains limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patient is older than 18 years with severe AS considered for TAVI by a multidisciplinary heart team.
* Patient is candidate for transfemoral TAVI as per local standards and current guidelines.
* Patient is willing and capable to give written consent to participate to the trial and confirmed to be able to attend the expected follow up visits.

Exclusion Criteria:

* Patient had a coronary angiogram with or without PCI and/or coronary CT and/or CABG within last 5 years.
* Left main PCI in the medical history
* Patient has CCS of 3 or more.
* Patient has left ventricular ejection fraction \<30%.
* Patients in whom TAVI through femoral access is ad priori not possible based on clinical assessment or medical history
* Patient has been treated for acute myocardial infarction within 30 days before randomization.
* Patient has a planned open-heart surgery.
* Patient has a life expectancy less than 1 year due to other severe non-cardiac disease.
* Patient is participating in another clinical study with an investigational product that has not yet completed the follow up period.
* Patient has received previous treatment for aortic valve implantation or replacement.
* Female patient who is pregnant at the time of inclusion and female patient of childbearing potential

Where this trial is running

Graz and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Severe Aortic StenosisPURE TAVI
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.