Status:
COMPLETED
The TransCatheter Valve and Vessels Trial
Lead Sponsor:
Maatschap Cardiologie Zwolle
Collaborating Sponsors:
Medtronic
Conditions:
Aortic Stenosis
Multi Vessel Coronary Artery Disease
Eligibility:
All Genders
70+ years
Phase:
NA
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...
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 a...
Eligibility Criteria
Inclusion
- 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)
- 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)
- Patients willing and capable to provide written informed consent
Exclusion
- Patients in cardiogenic shock or acute heart failure, requiring inotropic agents during procedure and/or i.v. diuretics \<48 hours before procedure
- Left ventricular ejection fraction \<30%
- Concomitant presence of other than aortic valve disease requiring intervention
- Previous CABG, SAVR, TAVI or thoracotomy for any other reason
- Bicuspid or unicuspid aortic valve
- Recent myocardial infarction (less than 2 weeks)
- Involvement of left main trifurcation (all three branches being larger than 2 mm)
- Expected total stent length more 60mm per vessel
- FFR measurement judged impossible
- Life expectancy \<1 year
- Known malignancy
- Contraindication for dual antiplatelet therapy or expected surgical intervention requiring interruption of Dual Antiplatelet Therapy (DAPT) in the first 6 months
- Reduced renal function (Glomerular Filtration Rate (GFR) \<29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5)
- Previous disabling stroke, Transient Ischemic Attack (TIA) in the last 6 months, or known severe stenosis of carotid or vertebral arteries
- Participation in other investigational clinical trials
Key Trial Info
Start Date :
May 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2024
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT03424941
Start Date
May 31 2018
End Date
June 26 2024
Last Update
January 9 2025
Active Locations (20)
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1
Medical University of Graz
Graz, Austria
2
General Hospital Vienna
Vienna, Austria
3
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark
4
CHU de Bordeaux
Bordeaux, France