RecruitingNot Applicable

Transfemoral TAVI With or Without Coronary Angiogram in Patients With Severe Aortic Stenosis (PURE TAVI)

Austria, Czechia, France620 participantsStarted 2025-08-08

Plain-language summary

This study will be conducted in patients with severe aortic stenosis who are referred for transcatheter aortic valve implantation (TAVI). TAVI is the recommended treatment for severe aortic stenosis. Currently, before undergoing TAVI, most patients undergo a coronary angiography to check whether the coronary arteries are blocked and to assist in appropriate valve sizing. If significant blockages are detected, they are treated before or during TAVI. However, many patients who undergo TAVI are older and often have additional cardiovascular conditions such as hypertension, diabetes, or obesity. These comorbidities increase the risk of complications related to coronary angiography, including kidney injury from contrast dye, bleeding, and vascular complications at the access site. As such, it remains uncertain whether routine coronary angiography is necessary for all patients undergoing TAVI, particularly those without symptoms suggestive of myocardial ischemia. This study aims to determine whether a TAVI treatment pathway without prior coronary angiography is non-inferior to the standard pathway that includes routine coronary angiography, with or without revascularization, in patients with severe aortic stenosis who do not have typical angina symptoms (defined as Canadian Cardiovascular Society Class \<3). "Non-inferior" means the study seeks to show that omitting routine coronary angiography is at least as effective and safe as the standard approach. All participants will receive a CE-certified Myval™ balloon-expandable transcatheter heart valve. This device is commercially available and designed to provide accurate positioning and reliable valve function. This is a multicentre, investigator-initiated clinical study sponsored by Rede Optimus (RO), Alte Steinhauserstrasse 1, 6330 Cham, Switzerland. RO conducts independent research to address unresolved questions in vascular medicine. The study is financially supported by Meril Life Sciences Pvt. Ltd., Bilakhia House, Survey No.135/139, Muktanand Marg, Chala, Vapi 396191, Gujarat, India. Approximately 620 patients will be enrolled across 20 centres in 7 European countries. The total study duration is expected to be 42 months, with an 18-month enrollment period and 24-month follow-up for each participant.

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite of all-cause death, spontaneous or periprocedural myocardial infarction, etc

Timeframe: at 12-months follow-up

Trial details

NCT IDNCT06898086

SponsorRede Optimus Hospitalar SA

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2027-10-30

Contact for this trial

Julie Bosiers

+32 479 64 37 60 julie.bosiers@redeoptimus.com

View on ClinicalTrials.gov More Severe Aortic Stenosis trials