CT-FFR-guided Strategy for In-stent Restenosis

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease; In-stent Restenosis
• Interventions: Diagnostic Test: CT-FFR; Diagnostic Test: Usual Care

• Registration Number: NCT05611190
• Lead Sponsor: Yan'an Affiliated Hospital of Kunming Medical University

Brief 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.

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 Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-11-08
• Last Update Submitted: 2022-11-08
• Study First Posted: 2022-11-09
• Last Update Posted: 2022-11-09
• Study Start: 2022-12-12
• Primary Completion: 2024-12-11
• Study Completion: 2025-12-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 294

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-FFR	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.
Usual Care	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.

Primary Outcome Measures

Name	Time	Method
12-month MACE	12 months	12-month Major Adverse Coronary Event (MACE) rates, defined as: 1. All cause death; 2. Non-fatal myocardial infarction (MI); 3. Ischemia-driven target vessel revascularization (TVR)

Secondary Outcome Measures

Name	Time	Method
Total costs	6-month, 12-month	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.
Seattle Angina Questionnaire	6-month, 12-month	angina status, will be assessed using the Seattle Angina Questionnaire
MACE	3-month, 6-month, 24-month, 36-month	MACE defined as: 1. All cause death; 2. Non-fatal MI; 3. Clinical-driven TVR
Rates of Target lesion failure (TLF)	3-month, 6-month, 24-month, 36-month	Composite of clinically driven TLR, MI or cardiac death related to the target vessel.
Quality of life (QOL) will be assessed using the EQ-5D-VAS questionnaire	6-month, 12-month	Quality of life (QOL), will be assessed using the EQ-5D-VAS questionnaire
Cumulative radiation exposure	6-month, 12-month	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.