Prospective study for early assessment of everolimus eluting platinum chromium alloy stent (Synergy) healing with optical coherence tomography

Prospective study for early assessment of everolimus eluting platinum chromium alloy stent (Synergy) healing with optical coherence tomography - Prospective study for early assessment of everolimus eluting platinum chromium alloy stent (Synergy) healing with optical coherence tomography

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022130

Enrollment

Registered

2016-04-28

Start date

2016-05-06

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

ischemic heart disease

Interventions

Evaluation for neointima with optical coherence tomography (OCT) imaging catheter at 2 weeks after Synergy implantation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who underwent percutaneous coronary intervention (PCI) for ischemic heart disease, and implanted Synergy stent 2) Patients who plan to undergo additional PCI for residual lesion 2 weeks later

Exclusion criteria

Exclusion criteria: 1) Patients with impaired renal function (eGFR <50ml/min/1.73m2) 2) Patients with severe heart failure (LVEF <30% or NYHA class > 3)

Design outcomes

Primary

Measure	Time frame
Percentage of covered struts at 2 weeks after Synergy implantation	—

Secondary

Measure	Time frame
1) Percentage of apposed struts at 2 weeks after Synergy implantation 2) Relation between patients background and the percentage of covered or apposed struts 3) The evaluation of mean stent area, lumen area, neointimal area, and relation between patients background and them. 4) Existence of thrombus, heterogeneity of neointima, neovascularization, stent edge dissection, and relation between patients background and them 5) Percentage of covered struts in the overlapping segments	—

Measure

Time frame

1) Percentage of apposed struts at 2 weeks after Synergy implantation 2) Relation between patients background and the percentage of covered or apposed struts 3) The evaluation of mean stent area, lumen area, neointimal area, and relation between patients background and them. 4) Existence of thrombus, heterogeneity of neointima, neovascularization, stent edge dissection, and relation between patients background and them 5) Percentage of covered struts in the overlapping segments

—

Countries

Japan

Contacts

Public ContactNorikiyo Oka

Chiba University Hospital Department of Cardiovascular Medicine

norikiyo.oka@ma.point.ne.jp043-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026