NL-OMON50705
Recruiting
N/A
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 - TCW
Maatschap Cardiologie Zwolle0 sites170 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- meervatslijden
- Sponsor
- Maatschap Cardiologie Zwolle
- Enrollment
- 170
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
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
- •8\) Expected total stent length more 60mm per vessel
Outcomes
Primary Outcomes
Not specified
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