Clinical trial NCT05611190: CT-FFR-guided Strategy for In-stent Restenosis
Official title: Coronary CT Angiography-Derived Fractional Flow Reserve-guided Optimize Treatment Strategy for In-stent Restenosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
In-stent Restenosis
Keywords: Coronary CT Angiography-derived Fractional Flow Reserve
In-stent Restenosis
Major Adverse Coronary Events
Lead sponsor: Yan'an Affiliated Hospital of Kunming Medical University
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 12-month MACE
timeFrame: 12 months
Secondary outcomes:
measure: MACE
timeFrame: 3-month, 6-month, 24-month, 36-month
measure: Rates of Target lesion failure (TLF)
timeFrame: 3-month, 6-month, 24-month, 36-month
measure: Total costs
timeFrame: 6-month, 12-month
measure: Quality of life (QOL) will be assessed using the EQ-5D-VAS questionnaire
timeFrame: 6-month, 12-month
measure: Seattle Angina Questionnaire
timeFrame: 6-month, 12-month
measure: Cumulative radiation exposure
timeFrame: 6-month, 12-month
Other outcomes:
Locations:
Study officials:
affiliation: Yan'an Affiliated Hospital of Kunming Medical University
name: Qiang Xue
role: PRINCIPAL_INVESTIGATOR
References: