A prospective multicenter registry for investigating outcomes of intravascular ultrasound (IVUS) guided tip detection method in chronic total occlusion (CTO) percutaneous coronary intervention (PCI)

A prospective multicenter registry for investigating outcomes of intravascular ultrasound (IVUS) guided tip detection method in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) - Tip detection CTO PCI Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057574

Enrollment

200

Registered

2025-04-10

Start date

2025-02-10

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

Coronary Artery Disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 20 years or older at the time of providing informed consent and who underwent PCI for chronic total occlusions that meet the following criteria for treatment with PCI: A) TIMI 0 (no continuous antegrade blood flow). B) Occlusion period > 3 months or unknown C) CTO in a major coronary artery (Seg 1-3, 5-8, 11, 13) or a coronary artery branch with significant perfusion area equivalent to a major coronary artery (Seg 4, 9/10,12) 2.Patients who are able and willing to visit the hospital for necessary follow-up visits and examinations

Exclusion criteria

Exclusion criteria: 1. Patients who are unable to give consent for the use of their information and have requested it. 2. Patients who are unable to receive antiplatelet therapy 3. Patients who are deemed by the investigator or co-investigator to be ineligible to participate in this study for any other reason.

Design outcomes

Primary

Measure	Time frame
Success rate of the TD method in CTO-PCI, Proportion of patients who successfully crossed the wire through the CTO lesion with the tip detection method and obtained good recanalization without contrast delay in the final angiography	—

Secondary

Measure	Time frame
Efficacy secondary endpoints -Procedure information and results of tip detection method (Intraplaque tracking or ADR selection criteria, device selection, procedure time, false lumen crossing distance, complications) -Evaluation of CTO-PCI procedure, radiation exposure, fluoroscopy time, contrast medium usage -Restenosis rate by coronary angiography during follow-up period (9 months) and revascularization rate during clinical follow-up period Safety secondary endpoints -Incidence of MACCE during hospitalization (all-cause death, cardiovascular death, myocardial infarction, revascularization, cerebral infarction) -MACCE during follow-up (9 months)	—

Measure

Time frame

Efficacy secondary endpoints -Procedure information and results of tip detection method (Intraplaque tracking or ADR selection criteria, device selection, procedure time, false lumen crossing distance, complications) -Evaluation of CTO-PCI procedure, radiation exposure, fluoroscopy time, contrast medium usage -Restenosis rate by coronary angiography during follow-up period (9 months) and revascularization rate during clinical follow-up period Safety secondary endpoints -Incidence of MACCE during hospitalization (all-cause death, cardiovascular death, myocardial infarction, revascularization, cerebral infarction) -MACCE during follow-up (9 months)

—

Countries

Japan

Contacts

Public ContactTomohiro, Kota Yamasaki, Tanaka

Sakurabashi Watanabe Advanced Healthcare Hospital Cardiovascular Center

doanditwillbedone77@gmail.com06-6676-8215

Outcome results