Impact of OCT guided imaging in decision making in PCI

Not Applicable

Completed

Conditions: Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery

Registration Number: CTRI/2018/10/015872

Lead Sponsor: isie Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 500

Inclusion Criteria

Patients of either sex aged >18 years

Patients willing to sign the informed consent form

Patients with significant coronary artery stenosis (diameter stenosis >70% based on visual assessment on the coronary angiogram) in at least one native coronary artery after angiography

Exclusion Criteria

Patients unwilling to sign the informed consent

Patients with hypotension, shock or need for mechanical support or intravenous vasopressors

Patients with extreme angulation ( >90â?°), or excessive vessel tortuosity

Patients with renal insufficiency (estimated glomerular filtration rate <50 ml/min/m2) or any other severe medical condition interfering with the patientsâ?? safety or study results

Patients with contraindications to dual antiplatelet therapy up to 1 year

Patients with other comorbidities that may limit life expectancy to less than one year

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in procedural strategy pre- and post PCI with ACR (Pre-PCI strategy change involves change in the intended stent length and size, and intended device landing zone; and post-PCI strategy change involves the intended need for additional interventional procedures for PCI optimization after identification of stent malapposition, edge dissections, and stent under expansion.Timepoint: 12 months

Secondary Outcome Measures

Name	Time	Method
Procedural outcomes with ACR-guided PCI in the entire study population <br/ ><br> <br/ ><br>Procedural outcomes with ACR-guided PCI in the sub-set of patients with complex coronary artery lesions, such as diffusely diseased vessel segments, or segments with missing anatomical landmarks <br/ ><br> <br/ ><br>Rate of MACE at 6 monthsâ?? and 1-year with ACR-guided PCI (death, myocardial infarction, target vessel revascularization [TVR] or target lesion revascularization [TLR])Timepoint: 12 months