Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care

Coronary Artery Disease Clinical Trial

— ADVANCE  

Official title:

Assessing Diagnostic Value of Non-invasive FFRCT in Coronary CarE (ADVANCE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02499679
• Other study ID #: CP-905-001
• Status: Completed
• Start date: July 2015
• Est. completion date: May 2019

Study information

• Verified date: August 2019
• Source: HeartFlow, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The objective of the HeartFlow ADVANCE Registry is to evaluate utility, clinical outcomes and resource utilization of FFRCT-guided evaluation in clinically stable, symptomatic patients with coronary artery disease (CAD) in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis and management of CAD.

Description:

REGISTRY OBJECTIVE

The objective of the HeartFlow ADVANCE Registry is to evaluate utility, clinical outcomes and resource utilization of FFRCT-guided evaluation in clinically stable, symptomatic patients with CAD in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis and management of CAD.

SPECIFIC OBJECTIVES:

1. To determine if the availability of FFRCT, in addition to coronary anatomy from the cCTA, will lead to a significant change in the coronary management plan.

2. To assess the real world outcomes of utilizing FFRCT to guide invasive management and/or medical treatment.

3. To assess resource utilization, following standard practice for diagnostic and treatment pathways incorporating FFRCT as the preferred CAD diagnostic test.

4. To provide society including patients, health care providers, and other stakeholders with information about which diagnostic technologies are most effective and efficient in managing patients with CAD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6384
• Est. completion date: May 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Provide written informed consent

2. Clinically stable, symptomatic patients who undergo cCTA and are diagnosed with CAD and meet eligibility criteria for FFRCT.

Exclusion Criteria:

1. cCTA showing no CAD

2. Uninterpretable cCTA by site assessment, in which severe artifacts prevent angiographic evaluation

3. Any active, serious, life-threatening disease with a life expectancy of less than 1 year

4. Inability to comply with follow-up requirements

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HeartFlow, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reclassification rate between the coronary management plan based on the review of the cCTA compared to the management plan based on FFRCT when obtained, as assessed by an independent review committee.		n/a: reclassification rate of management plan
Secondary	Rate of reclassification between Investigator management plan based on cCTA alone compared to actual clinical management		90 days
Secondary	Rate of invasive catheterization without obstructive disease		90 days
Secondary	Percent of patients undergoing revascularization within 90 days for whom functional data are available prior to revascularization		90 days
Secondary	Major Adverse Coronary Event (MACE) rates at 90 days, 180 days and 1 - 3 years	MACE is defined as the composite rate of all cause death, non-fatal myocardial infarction (MI) and unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization.	3 years
Secondary	Individual components of MACE at 90 days, 180 days, 1 - 3 years	Individual components of MACE defined as all cause death, non-fatal MI, unplanned hospitalization for ACS leading to urgent revascularization	3 years
Secondary	Estimated cumulative medical radiation exposure		1 year
Secondary	Resource Utilization at 90 days, 180 days, 1 - 3 years	Resource utilization composite defined as the composite of invasive diagnostic and therapeutic coronary procedures, treatment of MACE events, and noninvasive cardiac testing	3 years