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
- Conditions
- meervatslijdenmultivessel disease and aortic valve stenosis10046973
- Registration Number
- NL-OMON50705
- Lead Sponsor
- Maatschap Cardiologie Zwolle
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 170
1) Symptomatic patients aged >=70 years with AS fulfilling one of these criteria
(AVA <=1 cm2; mean gradient >=40mmHg; 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 HT decides that
treatment is needed (final decision is left to the HT)
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 LAD lesion with more than 20 mm
length or involving a bifurcation (complex), feasible for treatment with CABG
as well as PCI (HT decision)
3) Patients willing and capable to provide written informed consent
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 (GFR <29 ml/min/1.73m2; KDOQI stage 4 and 5)
14) Previous disabling stroke, TIA in the last 6 months, or known severe
stenosis of carotid or vertebral arteries
15) Participation in other investigational clinical trials
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is a composite of all-cause mortality, myocardial<br /><br>infarction, disabling stroke, unscheduled clinically-driven target vessel<br /><br>revascularization, valve re-intervention, and life threatening or disabling<br /><br>bleeding at one year</p><br>
- Secondary Outcome Measures
Name Time Method <p>- MACE (a composite of cardiovascular mortality, all stroke, myocardial<br /><br>infarction, unscheduled coronary or valve re-intervention) at one year<br /><br>- All-cause mortality and all stroke at 30 days and at one year</p><br>