Coronary Artery Disease Clinical Trial
— LIPSIASTRATEGYOfficial title:
Comparison of Non-Invasive Vessel Fractional Flow Reserve Calculated From Angiographic Images Versus Fractional Flow Reserve in Patients With Intermediate Coronary Artery Stenoses
This is a prospective, randomized, controlled, multicenter, open-label study designed to assess whether vFFR is non-inferior to FFR in assessment of intermediate coronary stenosis in terms of the occurrence of MACE during 12 months after randomization.
Status | Recruiting |
Enrollment | 1926 |
Est. completion date | November 1, 2026 |
Est. primary completion date | May 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age >18 years - Willing to participate and able to understand, read and sign the informed consent document before the planned procedure - Eligible for coronary angiography and/or PCI - Coronary artery disease in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed de novo coronary stenosis in which the physiological severity of the lesion is in question (typically 40-80% diameter stenosis). - Stable angina or acute coronary syndrome (non-culprit vessels only and outside of primary intervention during acute STEMI or NSTE-ACS) - Participation in another interventional study Exclusion Criteria: - Previous CABG with patent grafts to the interrogated vessel - Tandem stenoses separated by more than 10 mm that require separate pressure guide wire interrogation or PCI (not to be interrogated or treated as a single stenosis) - Total coronary occlusions - Hemodynamic instability (Killip class III-IV) - Heavily calcified or tortuous vessels - Terminal disease with life expectancy of less than 12 months - STEMI within 48 hours of procedure - Severe valvular heart disease - ACS patients with difficulty in assessing which the culprit lesion is - Significant contraindication to adenosine administration (e.g. Asthma bronchiale) - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Germany | Heart Center Dresden - University Clinic | Dresden | |
Germany | University Clinic Erlangen | Erlangen | |
Germany | Universitätsklinikum Essen | Essen | |
Germany | University Clinic Giessen and Marburg | Gießen | |
Germany | Herzzentrum Leipzig | Leipzig | |
Germany | University Clinic Leipzig | Leipzig | |
Germany | Klinikum der Stadt Ludwigshafen | Ludwigshafen | |
Germany | Lukaskrankenhaus Neuss | Neuss |
Lead Sponsor | Collaborator |
---|---|
Helios Health Institute GmbH | Heart Center Leipzig - University Hospital |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major Adverse Cardiac Event (MACE) rate | composite of cardiac death, non-fatal myocardial infarction or unplanned revascularization | 1 year | |
Secondary | MACE during long-term follow-up | 2 and 5 years | ||
Secondary | Each component of the primary endpoint assessed by structured telephone interview and verification by hospital reports | 1, 2 and 5 years | ||
Secondary | Repeat revascularization (PCI or CABG) assessed by structured telephone interview and verification by hospital reports in case of event | 1, 2 and 5 years | ||
Secondary | All-cause mortality | 1, 2 and 5 years | ||
Secondary | Cross-over rate from the one strategy to the other | at intervention | ||
Secondary | Number of analyzable lesions in both treatment arms | at intervention |
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 |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
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 |
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 | |
Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |