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

NCT03442400 | Terminated Results FDA Device

• 1 other identifier: IRB 17-695
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary artery blockages can reduce blood flow to the heart muscle. Fractional flow reserve (iFR or FFR) assessment is an invasive tool used to determine how much blood flow is reduced. The investigators will perform iFR/FFR on all intermediate coronary stenoses using standard practice, immediately before (at the time of) transcatheter aortic valve replacement (TAVR) and after successful TAVR. The investigators will compare pre- and post-TAVR iFR/FFR values, and assess short-term outcomes. The investigators hypothesize that iFR/FFR values will be consistently and significantly higher pre-TAVR in comparison with post-TAVR for the same lesions.

Conditions

Coronary Artery Stenoses; Aortic Stenosis

Keywords

Coronary Artery Stenoses; Aortic Stenosis

Outcome Measures

Primary Outcomes (2)

• FFR Values Prior to Transcatheter Aortic Valve Replacement

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

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

• FFR Values During the Transcatheter Aortic Valve Replacement (TAVR)

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

  Immediately after transcatheter aortic valve replacement, during the index procedure

Study Arms (1)

FFR/iFR arm

EXPERIMENTAL

Volcano iFR/FFR Verrata Plus coronary pressure/flow wire

Device: Volcano iFR/FFR Verrata Plus coronary pressure/flow wire

Interventions

Volcano iFR/FFR Verrata Plus coronary pressure/flow wire DEVICE

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/iFR arm

Eligibility Criteria

• Age: 20 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who have coronary stenoses between 40-70% severity and who have severe aortic stenosis undergoing TAVR work-up.

You may not qualify if:

• Patients with documented intraprocedural hemodynamic instability, shock, or major adverse event (myocardial infarction, aortic rupture/dissection, stroke, left ventricular perforation, cardiac arrest).
• Contraindication to adenosine, presence of cardiogenic shock, presence of acute coronary syndrome.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Volcano Corporation: collaborator

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Coronary Stenosis; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Samir Kapadia, MD
• Organization: Cleveland Clinic

kapadis@ccf.org

216-444-6735

Study Officials

• Samir R Kapadia, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single group of patients with severe aortic stenosis and intermediate coronary stenoses will undergo coronary physiology assessment with iFR/FFR before and after transcatheter aortic valve replacement.

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 22, 2018
• Study Start: February 14, 2018
• Primary Completion: August 10, 2021
• Study Completion: August 10, 2021
• Last Updated: January 5, 2023
• Results First Posted: January 5, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)