Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention … (NCT04310046) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
Austria, France, Germany986 participantsStarted 2020-09-30
Plain-language summary
The primary objective of this study is to compare, in patients with severe aortic stenosis and concomitant coronary artery disease accepted for transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) by the multidisciplinary Heart Team, the safety and efficacy of angiography-guided complete revascularization performed after (within 1-45 days) with angiography-guided complete revascularization performed before (within 1-45 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®.
Who can participate
Age range
18 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
. Patients ≥18 years with severe aortic stenosis and concomitant coronary artery disease accepted for transfemoral TAVI with an Edwards SAPIEN Transcatheter Heart Valve™ and PCI by a multidisciplinary Heart Team.
. Severe aortic stenosis defined as aortic valve area (AVA) ≤1.0 cm2 and/or mean pressure gradient ≥40 mmHg (echocardiography) and at least one of the following criteria:
. Dyspnea
. Angina symptoms
. Syncope
. Decline in left ventricular ejection fraction \<50%, symptoms or fall in blood pressure on exercise testing, or presence of high-risk criteria (peak transaortic velocity \>5.5 m/s, severe valve calcification, peak transaortic velocity progression ≥0.3 m/s per year, or severe pulmonary hypertension with systolic pulmonary artery pressure \>60 mmHg) according to current guidelines.
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.
1Since this trial is comparing different timing approaches for doing TAVI and PCI together — such as whether the procedures are done at the same time or staged separately — which approach is my doctor currently leaning toward for me, and what are the potential risks of each option?
2This trial is listed as 'active not recruiting,' meaning they're no longer enrolling new patients — does that affect my ability to participate, and are there similar studies still open that my doctor would recommend looking into?
3Because this trial involves both a heart valve procedure (TAVI) and a coronary artery procedure (PCI), how does combining or sequencing these two interventions affect my overall recovery time and risk compared to standard care?
4The trial doesn't specify a traditional phase, which suggests it may be more about comparing existing accepted procedures than testing a brand-new treatment — does my doctor think one timing approach already has enough evidence to guide my care, or is the uncertainty real enough that a trial like this matters for my decision?
5Given that I have both aortic stenosis and coronary artery disease, how would my doctor weigh the option of enrolling in a trial like this against simply following whatever timing approach they already consider best practice for my specific situation?
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
1
The primary outcome measure is the number of participants experiencing the primary outcome measure
. At least one coronary artery lesion with ≥70% diameter stenosis on coronary angiogram (by visual estimation) in a coronary artery ≥2.5 mm in diameter and Thrombolysis in Myocardial Infarction (TIMI) flow grade III, deemed amenable to PCI within 45 days before or after TAVI. Hemodynamic lesion assessment by fractional flow reserve (FFR), instantaneous wave-free ratio (iwFR), or comparable indices as well as intravascular imaging-guided PCI are left at the discretion of the operator.
. Written informed consent.
Exclusion criteria
. TAVI by transapical, subclavian, or transaortic access
. Admission with acute myocardial infarction within 30 days before randomization
. Elective coronary revascularization within 3 months before randomization
. Previous coronary artery bypass grafting (CABG)
. Syntax Score I ≥33
. Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 inhibitor (clopidogrel, ticagrelor or prasugrel), except for patients on oral anticoagulation