NCT03058627Active, not recruiting
Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation
Routine Revascularization With Percutaneous Coronary Intervention in Patients With Coronary Artery Disease Undergoing Transcatheter Aortic Valve Implantation - the Nordic Aortic Valve Intervention-3 Trial
Source: ClinicalTrials.gov · Last updated 19 Dec 2023
Brief summary (registry, in English)
The aim of this study is to evaluate the effect of routine FFR-guided complete revascularization with PCI compared to conservative management in patients with concomitant coronary artery disease who are undergoing TAVI.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 454 (actual)
- First submitted
- 11 Feb 2017
- Start date
- 15 Sept 2017
- Primary completion date
- 15 Jan 2024
- Lead sponsor
- Thomas Engstrom
- Diseases
- Coronary artery disease
- NCT number
- NCT03058627
What you commit to
- Study type: Interventional
- Participants enrolled: 454
- From 15 Sept 2017 to the primary completion date, 15 Jan 2024
- 12 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Life expectancy \< 1 year due to other severe non-cardiac disease
- Severe renal failure with estimated glomerular filtration rate \< 20 ml/min
- Admitted with a new acute coronary syndrome (ST-elevation myocardial infarction (STEMI) or non-STEMI) within 14 days
- Only stenoses with thrombolysis in myocardial infarction grad \< 3
- Known allergy towards P2Y12 receptor antagonists, heparin or contrast medium
Other
- No PCI-eligible coronary artery stenosis, but rotablation is allowed
- Significant stenosis in left main stenosis or ostial left anterior descending artery (LAD) + ostial left circumflex artery (LCx))
- Potential pregnancy
- More than one chronic total occlusion (CTO)
Who the study is looking for
- Age ≥ 18 years
- Severe aortic valve stenosis and selected for TAVI by a multi-disciplinary Heart Team
- At least one stenosis with FFR ≤ 0.80 or diameter stenosis \> 90% in a coronary artery ≥ 2.5 mm in diameter
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Unknown status |
| Department of Cardiology, Skejby University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Rigshospitalet (Copenhagen University Hospital) Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Department of Cardiology, Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| Helsinki University Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Unknown status |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Unknown status |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Unknown status |
| Riga University Hospital Coordinator of this site? Confirm its status | Riga | Latvia | Unknown status |
| Sahlgrenska Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Lund University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
| Karolinska Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.