NCT06898086: PURETAVI

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

Recruiting now NA Last updated 9 February 2026

What this trial tests

NA trial testing Transcatheter aortic valve implantation in Severe Aortic Stenosis in 620 participants. Currently enrolling.

Timeline

8 August 2025

Primary endpoint
30 October 2027

30 October 2028

Quick facts

Lead sponsor	Rede Optimus Hospitalar SA
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	620
Start date	8 August 2025
Primary completion	30 October 2027
Estimated completion	30 October 2028
Sites	23 locations across France, Italy, Netherlands, Austria, Germany, Switzerland, Czechia

Drugs / interventions tested

• Transcatheter aortic valve implantation

Conditions studied

• Severe Aortic Stenosis — all drugs for Severe Aortic Stenosis →

Sponsor

Rede Optimus Hospitalar SA

Who can join

Adults 18 to 120, any sex, with Severe Aortic Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.