CT-FFR-guided Strategy for In-stent Restenosis

Coronary CT Angiography-Derived Fractional Flow Reserve-guided Optimize Treatment Strategy for In-stent Restenosis

This study will be a prospective, randomized clinical trial to compare standard practice guided by usual care testing to CT-FFR-guided management in patients with in-stent restenosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; In-stent Restenosis
• Intervention / Treatment: Diagnostic test: Usual Care; Diagnostic test: CT-FFR

Detailed Description

This trial will randomize 294 patients with in-stent restenosis to receive either CT-FFR or routine clinical assessment. In all subjects, the investigators will review all diagnostic test results and determine a treatment strategy. The primary end point will be 12-month Major Adverse Coronary Event (MACE) rates, defined as all cause death, non-fatal myocardial infarction (MI), ischemia-driven target vessel revascularization (TVR). Secondary end points will include total medical costs, and quality of life (QOL), medical radiation exposure, etc. We will test noninferiority of current FFR-guided strategy compared with standard care strategy.

• Study Type: Interventional
• Enrollment (Anticipated): 294
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qiang Xue; Phone Number: 13987199913; Email: Xueqiang3513@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (1) >18 years old;
• (2) ability to provide informed consent;
• (3) previous PCI who underwent CCTA and have at least 1 lesion with a percent diameter in-stent stenosis between 30% and 90% in a coronary artery with a ≥2.25 mm reference vessel diameter by visual assessment;
• (4) accepted further clinically indicated coronary testing, coronary arteriography, or FFR, or IVUS, or PCI, etc.

Exclusion Criteria:

• (1) Prior coronary artery bypass surgery (CABG), heart valve surgery, cardiac pacemaker, or implanted cardiac defibrillator;
• (2) Target vascular stents were evaluated for implantation within one month;
• (3) unstable clinical conditions including acute chest pain, cardiogenic shock, congestive heart failure (NYHA grade III or IV), unstable blood pressure (systolic blood pressure < 90mmHg) or acute pulmonary edema;
• (4) Acute myocardial infarction occurred within 7 days before enrollment, and left ventricular ejection fraction ≤40%;
• (5) Other severe cases are not suitable for clinical trials including complex congenital heart disease, sick sinus syndrome, long QT syndrome, severe arrhythmia, tachycardia, severe asthma, severe or very severe chronic obstructive pulmonary disease (COPD) and severe chronic renal damage;
• (6) Contraindication to beta blockers, nitroglycerin, adenosine, or allergy to iodine contrast agents;
• (7) Pregnancy or pregnancy status unknown;
• (8) Life expectancy <1 years;
• (9)Repeated enrollment;
• (10) Any other factors that other researchers consider not suitable for inclusion or completion of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual Care; Participants randomized to usual care will be evaluated according to institutional standard practice. The investigators will review clinical data and results of the diagnostic tests to recommend a treatment strategy, according to the institution's standard practice.	Diagnostic test: Usual Care; Participants randomized to usual care will be evaluated according to institutional standard practice.
Experimental: CT-FFR; Participants randomized to a CT-FFR strategy will be assigned to non-invasive CT-FFR evaluation. The investigators will review the results CT-FFR, and will recommend a further ICA test if CT-FFR≤0.8. The investigators will review the results of all available diagnostic tests, including CT-FFR and ICA, and will recommend a treatment strategy accordingly.	Diagnostic test: CT-FFR; CT-FFR is a type of non-invasive procedure to provide a 3D model of coronary arteries as a way to evaluate the hemodynamic significance of coronary artery lesions. CT-FFR calculates FFR from subject-specific CCTA data using computational fluid dynamics technology. CT-FFR value ≤0.80 is considered hemodynamically significant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-month MACE	12-month Major Adverse Coronary Event (MACE) rates, defined as: All cause death; Non-fatal myocardial infarction (MI); Ischemia-driven target vessel revascularization (TVR)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	MACE defined as: All cause death; Non-fatal MI; Clinical-driven TVR	3-month, 6-month, 24-month, 36-month
Rates of Target lesion failure (TLF)	Composite of clinically driven TLR, MI or cardiac death related to the target vessel.	3-month, 6-month, 24-month, 36-month
Total costs	Total costs will be calculated from the use of all cardiac-related invasive and non-invasive tests, revascularization procedures, hospital admissions and outpatient attendances due to a cardiovascular cause, and cardiac medications.	6-month, 12-month
Quality of life (QOL) will be assessed using the EQ-5D-VAS questionnaire	Quality of life (QOL), will be assessed using the EQ-5D-VAS questionnaire	6-month, 12-month
Seattle Angina Questionnaire	angina status, will be assessed using the Seattle Angina Questionnaire	6-month, 12-month
Cumulative radiation exposure	Cumulative radiation exposure within 6-month and 12-month of study entry included all cardiovascular tests and invasive procedures, including CTA, myocardial perfusion imaging, and ICA.	6-month, 12-month

Collaborators and Investigators

• Sponsor: Yan'an Affiliated Hospital of Kunming Medical University
• Investigators: Principal Investigator: Qiang Xue, Yan'an Affiliated Hospital of Kunming Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 12, 2022
• Primary Completion (Anticipated): December 11, 2024
• Study Completion (Anticipated): December 11, 2025

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: In-stent Restenosis; Coronary CT Angiography-derived Fractional Flow Reserve; Major Adverse Coronary Events
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: In-stent Restenosis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No