Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03058627
Other study ID # H-16039929
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 15, 2017
Est. completion date November 15, 2027

Study information

Verified date December 2023
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 454
Est. completion date November 15, 2027
Est. primary completion date January 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Procedure:
PCI
FFR guided PCI

Locations

Country Name City State
Denmark 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
Finland Helsinki University Hospital Helsinki
Finland Oulu University Hospital Oulu
Finland Tampere University Hospital Tampere
Finland Turku University Hospital Turku
Latvia Riga University Hospital Riga
Sweden Sahlgrenska Gothenburg
Sweden Lund University Hospital Lund
Sweden Karolinska Stockholm

Sponsors (14)

Lead Sponsor Collaborator
Thomas Engstrom Aalborg University Hospital, Aarhus University Hospital, Haukeland University Hospital, Helsinki University Central Hospital, Karolinska University Hospital, Lund University Hospital, Odense University Hospital, Oulu University Hospital, Pauls Stradins Clinical University Hospital, Rigshospitalet, Denmark, Sahlgrenska University Hospital, Sweden, Tampere University Hospital, Turku University Hospital

Countries where clinical trial is conducted

Denmark,  Finland,  Latvia,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality, myocardial infarction, or urgent revascularization Number of patients experiencing all-cause mortality, myocardial infarction, or urgent PCI Until the last included patients have been followed for 1 year after the TAVI
Secondary All cause mortality Number of patients experiencing all cause mortality Until the last included patients have been followed for 1 year after the TAVI
Secondary Myocardial infarction Number of patients experiencing myocardial infarction Until the last included patients have been followed for 1 year after the TAVI
Secondary Urgent revascularization Number of patients experiencing urgent revascularization Until the last included patients have been followed for 1 year after the TAVI
Secondary All cause mortality or myocardial infarction Number of patients experiencing all cause mortality or myocardial infarction Until the last included patients have been followed for 1 year after the TAVI
Secondary Cardiovascular mortality Number of patients experiencing cardiovascular mortality Until the last included patients have been followed for 1 year after the TAVI
Secondary Cardiovascular mortality, myocardial infarction, or urgent PCI Number of patients experiencing cardiovascular mortality, myocardial infarction, or urgent PCI Until the last included patients have been followed for 1 year after the TAVI
Secondary Cardiovascular mortality or myocardial infarction Number of patients experiencing cardiovascular mortality or myocardial infarction Until the last included patients have been followed for 1 year after the TAVI
Secondary Admission for new onset of heart failure Number of patients experiencing admission for new onset of heart failure Until the last included patients have been followed for 1 year after the TAVI
Secondary Peri-procedural (PCI) myocardial infarction Number of patients experiencing peri-procedural (PCI) myocardial infarction Until the last included patients have been followed for 1 year after the TAVI
Secondary Peri-procedural (TAVI) myocardial infarction Number of patients experiencing peri-procedural (TAVI) myocardial infarction Until the last included patients have been followed for 1 year after the TAVI
Secondary Any revascularization Number of patients experiencing any revascularization Until the last included patients have been followed for 1 year after the TAVI
Secondary Stroke or transient ischemic attack (TIA) Number of patients experiencing stroke or transient ischemic attack (TIA) Until the last included patients have been followed for 1 year after the TAVI
Secondary Angina status (Seattle questionnaire), CCS and NYHA class Number of patients experiencing CCS and NYHA class 30 days and 1 year
Secondary Bleeding Number of patients experiencing bleeding Until the last included patients have been followed for 1 year after the TAVI
Secondary Quality of Life Number of patients experiencing improvement in Quality of life 30 days and 1 year
Secondary Acute kidney injury Number of patients experiencing acute kidney injury Until the last included patients have been followed for 1 year after the TAVI
Secondary Target vessel revascularization Number of patients experiencing target vessel revascularization Until the last included patients have been followed for 1 year after the TAVI
Secondary Target lession revascularization Number of patients experiencing target lession revascularization Until the last included patients have been followed for 1 year after the TAVI
Secondary Cost effectiveness analysis Cost effectiveness analysis Until the last included patients have been followed for 1 year after the TAVI
Secondary Stent thrombosis Number of patients experiencing stent thrombosis Until the last included patients have been followed for 1 year after the TAVI
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions N/A