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A prospective, single-centre study to investigate the role of Optical Coherence Tomography and fractional flow reserve for post coronary angioplasty stent optimisation

A prospective, single centre study to investigate volumetric methods for stent expansion by using Optical Coherence Tomographic parameters and its correlation with physiological evaluation and clinical outcomes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/032543
Enrollment
50
Registered
2021-04-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I208- Other forms of angina pectoris

Interventions

Intervention1: Pre Percutaneous intervention Optical coherence tomography and post Percutaneous intervention Optical coherence tomography: All eligible patients of stable ischemic heart disease who c

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients >= 18 and At least >=1 de novo lesions in a native coronary segment with a visually estimated diameter stenosis between >= 50 % and Patient understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect

Exclusion criteria

Exclusion criteria: Patients with USA/NSTEMI or ST elevation myocardial infarction Clinical instability with compromised hemodynamics Patients with a medical condition that limits the life expectancy to less than one year Patients scheduled to undergo surgery within 3 months that requires interruption of DAPT Women who are pregnant or planning to be pregnant Patients with allergy to contrast agents Patients with coronary artery bypass graft Patients with a history of adverse reactions to aspirin, clopidogrel, or prasugrel Patients in whom optimum OCT image acquisition is not feasible Patients with chronic renal failure

Design outcomes

Primary

MeasureTime frame
Correlation of OCT stent Optimization parameters with post PCI FFR (primary)Timepoint: immediately after the procedure

Secondary

MeasureTime frame
MACE (cardiovascular death, non-fatal myocardial infarction or target vessel revascularization, CVA) at 6 months follow up (secondary)Timepoint: 6 months

Countries

India

Contacts

Public ContactAnil Kumar Abbot

PGIMER Chandigarh

rajeshvijay999@hotmail.com9815221856

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026