CT-FFR-guided Strategy for In-stent Restenosis

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05611190
• Other study ID #: In-stent Restenosis
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: December 11, 2025

Study information

• Verified date: November 2022
• Source: Yan'an Affiliated Hospital of Kunming Medical University
• Contact: Qiang Xue
• Phone: 13987199913
• Email: Xueqiang3513[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 294
• Est. completion date: December 11, 2025
• Est. primary completion date: December 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• In-stent Restenosis

Intervention

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.
• Usual Care
Participants randomized to usual care will be evaluated according to institutional standard practice.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yan'an Affiliated Hospital of Kunming Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MACE	MACE defined as: All cause death; Non-fatal MI; Clinical-driven TVR	3-month, 6-month, 24-month, 36-month
Secondary	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
Secondary	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
Secondary	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
Secondary	Seattle Angina Questionnaire	angina status, will be assessed using the Seattle Angina Questionnaire	6-month, 12-month
Secondary	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