Brief Title
The TransCatheter Valve and Vessels Trial
Official Title
TransCatheter Aortic Valve Implantation and Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Versus Conventional Surgical Aortic Valve Replacement and Coronary By-Pass Grafts for Treatment of Patients With Coronary MultiVessel Disease and Aortic Valve Stenosis
Brief Summary
The trial objective is to investigate whether Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention (PCI) and TransCatheter Aortic Valve Implantation (TAVI) strategy for treatment of multivessel disease and aortic stenosis will be non-inferior to Coronary Artery By-pass Grafting (CABG) and Surgical Aortic Valve Replacement (SAVR) for a composite primary endpoint of all-cause mortality, stroke, myocardial infarction, coronary or valve re-intervention and life-threatening or disabling bleeding at one year.
Detailed Description
Prospective, randomized, controlled, open label, multicenter, international, non-inferiority trial If the Heart Team decides that a coronary revascularization and aortic valve replacement is needed and the patient complies with inclusion and exclusion criteria then the patient will be randomized in a 1:1 fashion between FFR-guided PCI + TAVI and CABG + SAVR. Patients will receive optimal medical treatment at discharge. Follow-up will be performed at 30 days and at one year. During the 30 day follow-up visit (after TAVI) patients will be evaluated for symptoms of angina.
Study Type
Interventional
Primary Outcome
The primary endpoint is a composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve re-intervention, and life threatening or disabling bleeding at one year
Secondary Outcome
Major Adverse Cardiac Events (MACE: a composite of cardiovascular mortality, all stroke, myocardial infarction, unscheduled coronary or valve re-intervention) at one year
Condition
Aortic Stenosis
Intervention
FFR-guided PCI and TAVI
Study Arms / Comparison Groups
FFR-guided PCI and TAVI
Description: FFR-guided PCI and subsequently TAVI treatment with the Medtronic CoreValve Evolut R or Medtronic CoreValve Evolut R PRO
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
328
Start Date
May 31, 2018
Completion Date
November 1, 2024
Primary Completion Date
November 1, 2023
Eligibility Criteria
Inclusion Criteria: 1. Symptomatic patients aged ≥70 years with aortic stenosis fulfilling one of these criteria (Aortic Valve Area (AVA) ≤1 cm2; mean gradient ≥40 mmHg; Aortic jet velocity >4 m/sec; or Velocity index ≤ 0.25) feasible for treatment by both trans femoral or subclavian approach TAVI as well as conventional SAVR and where the Heart Team decides that treatment is needed (final decision is left to the Heart Team) 2. Presence of ≥2 de novo coronary lesions of ≥50% diameter stenosis on visual estimation located in any of main epicardial coronary arteries, or side branches of a lumen caliber of more than 2 mm or single Left Anterior Descending (LAD) lesion with more than 20 mm length or involving a bifurcation (complex), feasible for treatment with CABG as well as PCI (Heart Team decision) 3. Patients willing and capable to provide written informed consent Exclusion Criteria: 1. Patients in cardiogenic shock or acute heart failure, requiring inotropic agents during procedure and/or i.v. diuretics <48 hours before procedure 2. Left ventricular ejection fraction <30% 3. Concomitant presence of other than aortic valve disease requiring intervention 4. Previous CABG, SAVR, TAVI or thoracotomy for any other reason 5. Bicuspid or unicuspid aortic valve 6. Recent myocardial infarction (less than 2 weeks) 7. Involvement of left main trifurcation (all three branches being larger than 2 mm) 8. Expected total stent length more 60mm per vessel 9. FFR measurement judged impossible 10. Life expectancy <1 year 11. Known malignancy 12. Contraindication for dual antiplatelet therapy or expected surgical intervention requiring interruption of Dual Antiplatelet Therapy (DAPT) in the first 6 months 13. Reduced renal function (Glomerular Filtration Rate (GFR) <29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5) 14. Previous disabling stroke, Transient Ischemic Attack (TIA) in the last 6 months, or known severe stenosis of carotid or vertebral arteries 15. Participation in other investigational clinical trials
Gender
All
Ages
70 Years - N/A
Accepts Healthy Volunteers
No
Contacts
prof. Elvin Kedhi, MD, PhD, +31 384262999, [email protected]
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT03424941
Organization ID
9283
Responsible Party
Sponsor
Study Sponsor
Maatschap Cardiologie Zwolle
Collaborators
Medtronic
Study Sponsor
prof. Elvin Kedhi, MD, PhD, Principal Investigator, Hopital Erasme, Brussels, Belgium
Verification Date
July 2022