Trial Outcomes & Findings for A Prospective Study of Fractional Flow Reserve Assessment of Intermediate Coronary Stenoses in Severe Aortic Stenosis (NCT NCT03442400)

NCT ID: NCT03442400

Last Updated: 2023-01-05

Results Overview

Hemodynamic significance of a coronary stenosis by measuring FFR immediately prior to TAVR

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: Immediately prior to transcatheter aortic valve replacement, during the index procedure
• Results posted on: 2023-01-05

Participant Flow

Participant milestones

Measure	FFR/iFR Arm Volcano iFR/FFR Verrata Plus coronary pressure/flow wire Volcano iFR/FFR Verrata Plus coronary pressure/flow wire: We will measure the degree of flow-limitation of intermediate severity coronary steonses using the iFR/FFR Verrata Plus coronary pressure/flow wire before and after transcatheter aortic valve replacement.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Prospective Study of Fractional Flow Reserve Assessment of Intermediate Coronary Stenoses in Severe Aortic Stenosis

Baseline characteristics by cohort

Measure	FFR/iFR Arm n=5 Participants Volcano iFR/FFR Verrata Plus coronary pressure/flow wire Volcano iFR/FFR Verrata Plus coronary pressure/flow wire: We will measure the degree of flow-limitation of intermediate severity coronary steonses using the iFR/FFR Verrata Plus coronary pressure/flow wire before and after transcatheter aortic valve replacement.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Diabetes	2 Participants n=5 Participants
Hypertension	5 Participants n=5 Participants
Hyperlipidemia	5 Participants n=5 Participants
Kidney disease	0 Participants n=5 Participants
Previous percutaneous coronary intervention	0 Participants n=5 Participants
Previous MI	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately prior to transcatheter aortic valve replacement, during the index procedure

Population: 1 patient did not have the FFR value documented

Hemodynamic significance of a coronary stenosis by measuring FFR immediately prior to TAVR

Outcome measures

Measure	FFR/iFR Arm n=4 Participants Volcano iFR/FFR Verrata Plus coronary pressure/flow wire Volcano iFR/FFR Verrata Plus coronary pressure/flow wire: We will measure the degree of flow-limitation of intermediate severity coronary steonses using the iFR/FFR Verrata Plus coronary pressure/flow wire before and after transcatheter aortic valve replacement.
FFR Values Prior to Transcatheter Aortic Valve Replacement	0.86 ratio Standard Error 0.0330088372006

PRIMARY outcome

Timeframe: Immediately after transcatheter aortic valve replacement, during the index procedure

Population: 1 patient did not have the FFR value documented

Hemodynamic significance of a coronary stenosis by measuring FFR immediately after TAVR

Outcome measures

Measure	FFR/iFR Arm n=4 Participants Volcano iFR/FFR Verrata Plus coronary pressure/flow wire Volcano iFR/FFR Verrata Plus coronary pressure/flow wire: We will measure the degree of flow-limitation of intermediate severity coronary steonses using the iFR/FFR Verrata Plus coronary pressure/flow wire before and after transcatheter aortic valve replacement.
FFR Values During the Transcatheter Aortic Valve Replacement (TAVR)	0.91 ratio Standard Error 0.0335099487715

Adverse Events

Interventional Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Samir Kapadia, MD

Cleveland Clinic

Phone: 216-444-6735

Email: kapadis@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place