Functional Lesion Assessment of Intermediate stenosis to guide Revascularisatio

Completed

Conditions: coronary artery disease
coronary narrowing
10011082

Registration Number: NL-OMON38052

Lead Sponsor: Imperial College London

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 210

Inclusion Criteria

1. Age>18 years of age
2. Willing to participate and able to understand, read, and sign the informed consent document before the planned procedure.
3. Eligible for coronary angiography and/or percutaneous coronary intervention
4. Coronary artery disease in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed de novo coronary stenosis in which the physiological severity of the lesion is in question (typically 40-70% diameter stenosis).
5. Stable angina or ACS (non-culprit vessels only and outside of primary intervention during acute STEMI)

Exclusion Criteria

1. Previous CABG with patents grafts to the interrogated vessel
2. Left main stenosis
3. Tandem stenoses separated by more than 10mm that require separate pressure guide wire interrogation or PCI (not to be interrogated or treated as a single stenosis).
4. total coronary occlusions.
5. Restenotic lesions.
6. Haemodynamic instability at the time of intervention (heart rate<50 beats per minute, systolic blood pressure <90mmHg, balloon pump).
7. Significant contraindication to adenosine administration (e.g. heart block, severe asthma).
8. Contraindications to PCI or drug-eluting stent (DES) implantation.
9. Heavily calcified or tortuous vessels
10. Significant hepatic or lung disease (chronic pulmonary obstructive disease), and/or malignant disease with unfavourable prognosis that may influence survival within the next 5 years.
11. Pregnancy
12. STEMI wihin 48 hours of procedure.
13. Severe valvular disease.
14. ACS patients in whom more than one target vessel is present.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Major adverse cardiac events (MACE) rate in the oFR and FFR groups at 30 days,<br /><br>1, 2, and 5 years.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Death (all cause) at 30 days, 1, 2, and 5 years.<br /><br>2. Death (cardiovascular) at 30 days, 1, 2, and 5 years.<br /><br>3. Myocardial infarction at 30 days, 1, 2, and 5 years.<br /><br>4. Repeat revascularization by PCI or coronary artery bypass graft surgery<br /><br>(CABG) at 30 days, 1, 2, and 5 years.<br /><br>5. Costs associated with iFR or FFR guidance.<br /><br>6. Quality of Lide (QOL) of patients included in the iFR or FFR guidance groups<br /><br>7. Cost savings of removing secondary inverigations, by assessing.treating<br /><br>non-culprit acute coronary syndrome (ACS) at the time of index presentation.</p><br>