Trial Outcomes & Findings for COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis. (NCT NCT04420325)
NCT ID: NCT04420325
Last Updated: 2025-09-05
Results Overview
Aortic valve intervention can potentially result in a change in fractional flow reserve (FFR) 6 months after SAVR/TAVI. FFR is the ratio of two intra-coronary measurements (Distal coronary pressure divided by proximal coronary pressure) and can range from 0.0-1.0. A lower FFR means that the lesion is more severe and therefore a higher FFR is considered better. The threshold to speak about hemodynamic significant of a lesion is 0.80. If the lesion has an FFR of ≤ 0.80 means the lesions is significant and treatment is necessary.
COMPLETED
116 participants
6 months
2025-09-05
Participant Flow
Participant milestones
| Measure |
Entire Study Population
Patients with AS undergoing TAVI or SAVR
|
|---|---|
|
Overall Study
STARTED
|
116
|
|
Overall Study
COMPLETED
|
84
|
|
Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis.
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=116 Participants
Patients with AS undergoing TAVI or SAVR
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
110 Participants
n=5 Participants
|
|
Age, Continuous
|
79.48 years
STANDARD_DEVIATION 8.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
116 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
116 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsAortic valve intervention can potentially result in a change in fractional flow reserve (FFR) 6 months after SAVR/TAVI. FFR is the ratio of two intra-coronary measurements (Distal coronary pressure divided by proximal coronary pressure) and can range from 0.0-1.0. A lower FFR means that the lesion is more severe and therefore a higher FFR is considered better. The threshold to speak about hemodynamic significant of a lesion is 0.80. If the lesion has an FFR of ≤ 0.80 means the lesions is significant and treatment is necessary.
Outcome measures
| Measure |
Entire Study Population
n=116 Participants
Patients with AS undergoing TAVI or SAVR
|
|---|---|
|
FFR 6 Months After SAVR/TAVI.
|
-0.0279 ratio
Standard Deviation 0.0368
|
SECONDARY outcome
Timeframe: 6 monthsMeasurement of IMR in patients with AS prior to intervention and 6 months after TAVI/SAVR. IMR is unitless and gives a description of coronary microvascular resistance, it can range from 0-100. Lower values are considered better as they are related with better microvascular function and health. If the IMR \> 25 we say microvascular dysfunction is present and treatment is considered necessary.
Outcome measures
| Measure |
Entire Study Population
n=116 Participants
Patients with AS undergoing TAVI or SAVR
|
|---|---|
|
IMR 6 Months After SAVR/TAVI.
|
-2.8150 Unitless
Standard Deviation 12.1600
|
SECONDARY outcome
Timeframe: BaselineComparison of the diagnostic performance of FFR versus RFR compared with SPECT ischemia. The higher the Area under the curve the better. The range is 0.0-1.0. An area under the curve for a ROC model is considered excellent if \> 0.8.
Outcome measures
| Measure |
Entire Study Population
n=116 Participants
Patients with AS undergoing TAVI or SAVR
|
|---|---|
|
FFR Versus RFR to Determine Ischemia.
|
0.8719 probability
Interval 0.804 to 0.9397
|
Adverse Events
Entire Study Population
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place