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Compares treatment options for Coronary Artery Disease
Official title Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
ClinicalTrials.gov ID: NCT03497637
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Stable angina or acute coronary syndrome (non-culprit vessels only and outside of primary intervention during acute STEMI or NSTE-ACS)
You likely can't join if
- 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...
- Total coronary occlusions
- Hemodynamic instability (Killip class III-IV)
- Heavily calcified or tortuous vessels
- Terminal disease with life expectancy of less than 12 months
See the full eligibility 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...
- Stable angina or acute coronary syndrome (non-culprit vessels only and outside of primary intervention during acute STEMI or NSTE-ACS)
- Participation in another treatment study
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Dresden, Germany
- Erlangen, Germany
- Essen, Germany
- Giessen, Germany
- Leipzig, Germany
- Ludwigshafen, Germany
- Neuss, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dresden, Germany; Erlangen, Germany; Essen, Germany; Giessen, Germany; Leipzig, Germany; Ludwigshafen, Germany and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.