Plaque mOrphology iMpact on Side Branch Occlusion at oPtical Coherence Tomography Evaluation in Percutaneous Coronary Interventions

NCT04501549 | Unknown

• 1 other identifier: 2018/2493
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Despite recent advances in interventional cardiology, bifurcation coronary artery stenoses (which account for 15-20% of all coronary lesions treated by PCI), remain a challenge for PCI operators with higher rates of failure, in-stent restenosis, stent thrombosis, and recurrent clinical events, when compared to simple non-bifurcation lesions. POMPEI trial is a prospective observational study. We aim to investigate the impact of morphological plaque characteristics assessed by optical coherence tomography (OCT) on the risk of developing side branch occlusion (SBO) in bifurcation PCI. A total of 27 patients undergoing bifurcation PCI will be recruited into the trial. PCI will be performed according to local practice.The bifurcation lesion will be imaged by OCT on at least two time-points for each patient. Plaque morphology will be characterized by OCT. Off-line quantitative coronary angiography (QCA) will be performed before and after PCI and the following QCA parameters will be computed: reference vessel diameter (RVD), lesion length and diameter stenosis (DS) of Main Vessel (MV) and side branch (SB). Blood samples will be taken prior to PCI and 8-12 hours later to determine peri-procedural myocardial injury and infarction following PCI by measuring serum Troponin. The OCT data analysis will be performed in collaboration with Dr Valeria Paradies who has been trained in interventional cardiology in Rotterdam (The Netherlands) with specific interest in intravascular imaging. In conclusion, we will use OCT to detect specific morphological characteristics which are associated with acute SBO following main vessel stenting. The routine use of OCT during bifurcation PCI to detect those patients at risk of acute SBO following main vessel stenting will allow the PCI operator to implement measures for reducing the risk of SBO, thereby minimizing the risk of peri- and post-PCI angina, preventing peri-procedural myocardial injury and infarction, and improving clinical outcomes.

Conditions

Bifurcation; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• To undertake a proof-of-concept clinical study to investigate the impact of morphological plaque characteristics on the risk of developing SBO in bifurcation lesion treatment

  If we can show that different culprit plaques behave differently, then there is the potential to undertake a larger study to change the way we manage these plaques and therapies to prevent SBO.

  1year

Interventions

percutaneous coronary intervention PROCEDURE

PCI will be performed according to local practice.The bifurcation lesion will be imaged by OCT on at least two time-points for each patient. Plaque morphology will be characterized by OCT. Off-line quantitative coronary angiography (QCA) will be performed before and after PCI and the following QCA parameters will be computed: reference vessel diameter (RVD), lesion length and diameter stenosis (DS) of Main Vessel (MV) and side branch (SB). Blood samples will be taken prior to PCI and 8-12 hours later to determine peri-procedural myocardial injury and infarction following PCI by measuring serum Troponin.

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatient waiting lists will be screened for patients undergoing election PCI for known bifurcation lesions. Patients will also be recruited after the elective PCI procedure. Patients who have undergone elective PCI for a bifurcation lesion which fits the criteria below, and had OCT performed during the procedure for clinical reasons.

You may qualify if:

• Age≥21 years of age
• Able to provide consent
• At least one de-novo bifurcation lesion involving a side-branch (SB) ≥ 2mm and SB ostial lesion ≥50% and \<90% by visual assessment intended to be treated by PCI with provisional stenting strategy
• TIMI flow 3 in both MV and SB

You may not qualify if:

• Previous PCI of the target vessel
• Cardiac arrest or cardiogenic shock
• Left main or saphenous venous graft bifurcation
• Significant renal impairment patients (eGFR\<30) who are not on dialysis
• Inability to advance the OCT catheter or to obtain good image quality

Sponsors & Collaborators

• National Heart Centre Singapore: lead

Study Sites (1)

National Heart Centre Singapore

Singapore, 169609, Singapore

RECRUITING

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Chin Chee Yang, MD

  National Heart Centre Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VANESSA WAN

CONTACT

+6567062273; vanessa.wan@nhcs.com.sg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 6, 2020
• Study Start: July 23, 2018
• Primary Completion: April 14, 2021
• Study Completion: April 14, 2021
• Last Updated: August 6, 2020

Record last verified: 2020-08

Locations

SG (1)