Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation

Not Applicable

Active, not recruiting

• Conditions: PCI; TAVI; Coronary Artery Disease; Aortic Valve Stenosis

• Registration Number: NCT03058627
• Lead Sponsor: Thomas Engstrom

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-11
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-23
• Study Start: 2017-09-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-19
• Primary Completion: 2024-01-15
• Study Completion: 2027-11-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 454

Inclusion Criteria

1. Age ≥ 18 years
2. Severe aortic valve stenosis and selected for TAVI by a multi-disciplinary Heart Team
3. At least one stenosis with FFR ≤ 0.80 or diameter stenosis > 90% in a coronary artery ≥ 2.5 mm in diameter

Exclusion Criteria

1. Life expectancy < 1 year due to other severe non-cardiac disease
2. Severe renal failure with estimated glomerular filtration rate < 20 ml/min
3. No PCI-eligible coronary artery stenosis, but rotablation is allowed
4. Admitted with a new acute coronary syndrome (ST-elevation myocardial infarction (STEMI) or non-STEMI) within 14 days
5. Significant stenosis in left main stenosis or ostial left anterior descending artery (LAD) + ostial left circumflex artery (LCx))
6. Only stenoses with thrombolysis in myocardial infarction grad < 3
7. Potential pregnancy
8. Known allergy towards P2Y12 receptor antagonists, heparin or contrast medium
9. More than one chronic total occlusion (CTO)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
All-cause mortality, myocardial infarction, or urgent revascularization	Until the last included patients have been followed for 1 year after the TAVI	Number of patients experiencing all-cause mortality, myocardial infarction, or urgent PCI

Secondary Outcome Measures

Name	Time	Method
Peri-procedural (TAVI) myocardial infarction	Until the last included patients have been followed for 1 year after the TAVI	Number of patients experiencing peri-procedural (TAVI) myocardial infarction
Target lession revascularization	Until the last included patients have been followed for 1 year after the TAVI	Number of patients experiencing target lession revascularization
Myocardial infarction	Until the last included patients have been followed for 1 year after the TAVI	Number of patients experiencing myocardial infarction
Urgent revascularization	Until the last included patients have been followed for 1 year after the TAVI	Number of patients experiencing urgent revascularization
Cardiovascular mortality, myocardial infarction, or urgent PCI	Until the last included patients have been followed for 1 year after the TAVI	Number of patients experiencing cardiovascular mortality, myocardial infarction, or urgent PCI
Peri-procedural (PCI) myocardial infarction	Until the last included patients have been followed for 1 year after the TAVI	Number of patients experiencing peri-procedural (PCI) myocardial infarction
Any revascularization	Until the last included patients have been followed for 1 year after the TAVI	Number of patients experiencing any revascularization
Stroke or transient ischemic attack (TIA)	Until the last included patients have been followed for 1 year after the TAVI	Number of patients experiencing stroke or transient ischemic attack (TIA)
Stent thrombosis	Until the last included patients have been followed for 1 year after the TAVI	Number of patients experiencing stent thrombosis
All cause mortality or myocardial infarction	Until the last included patients have been followed for 1 year after the TAVI	Number of patients experiencing all cause mortality or myocardial infarction
Admission for new onset of heart failure	Until the last included patients have been followed for 1 year after the TAVI	Number of patients experiencing admission for new onset of heart failure
Acute kidney injury	Until the last included patients have been followed for 1 year after the TAVI	Number of patients experiencing acute kidney injury
Target vessel revascularization	Until the last included patients have been followed for 1 year after the TAVI	Number of patients experiencing target vessel revascularization
All cause mortality	Until the last included patients have been followed for 1 year after the TAVI	Number of patients experiencing all cause mortality
Cardiovascular mortality	Until the last included patients have been followed for 1 year after the TAVI	Number of patients experiencing cardiovascular mortality
Cardiovascular mortality or myocardial infarction	Until the last included patients have been followed for 1 year after the TAVI	Number of patients experiencing cardiovascular mortality or myocardial infarction
Angina status (Seattle questionnaire), CCS and NYHA class	30 days and 1 year	Number of patients experiencing CCS and NYHA class
Bleeding	Until the last included patients have been followed for 1 year after the TAVI	Number of patients experiencing bleeding
Quality of Life	30 days and 1 year	Number of patients experiencing improvement in Quality of life
Cost effectiveness analysis	Until the last included patients have been followed for 1 year after the TAVI	Cost effectiveness analysis

Trial Locations

Locations (12)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Department of Cardiology, Skejby University Hospital; 🇩🇰 Aarhus, Denmark

Rigshospitalet, Copenhagen University Hospital; 🇩🇰 Copenhagen, Denmark

Department of Cardiology, Odense University Hospital; 🇩🇰 Odense, Denmark

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Turku University Hospital; 🇫🇮 Turku, Finland

Riga University Hospital; 🇱🇻 Riga, Latvia

Sahlgrenska; 🇸🇪 Gothenburg, Sweden

Scroll for more (2 remaining)