CT-FFR-guided Strategy for In-stent Restenosis

NCT05611190 | Unknown

• 1 other identifier: In-stent Restenosis
• Study Type: interventional
• Target: 294
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease; In-stent Restenosis

Keywords

Coronary CT Angiography-derived Fractional Flow Reserve; In-stent Restenosis; Major Adverse Coronary Events

Outcome Measures

Primary Outcomes (1)

• 12-month MACE

  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)

  12 months

Secondary Outcomes (6)

• MACE

  3-month, 6-month, 24-month, 36-month

• Rates of Target lesion failure (TLF)

  3-month, 6-month, 24-month, 36-month

• Total costs

  6-month, 12-month

• Quality of life (QOL) will be assessed using the EQ-5D-VAS questionnaire

  6-month, 12-month

• Seattle Angina Questionnaire

  6-month, 12-month

Study Arms (2)

Usual Care

OTHER

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

CT-FFR

EXPERIMENTAL

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

Interventions

CT-FFR DIAGNOSTIC_TEST

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.

CT-FFR

Usual Care DIAGNOSTIC_TEST

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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;

Sponsors & Collaborators

• Yan'an Affiliated Hospital of Kunming Medical University: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Qiang Xue

  Yan'an Affiliated Hospital of Kunming Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiang Xue

CONTACT

13987199913; Xueqiang3513@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 9, 2022
• Study Start: December 12, 2022
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2025
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share