NCT05800002

Brief Summary

Coronary calcified lesion is associated with a poor clinical outcome. Intravascular ultrasound (IVUS) provides anatomic information in detail about reference vessel dimensions and lesion characteristics including severity of diameter stenosis, lesion length, and morphology. Both randomized and observational studies have reported the clinical benefits of IVUS guidance for patients with chronic total occlusion (CTO), long lesions, acute coronary syndrome (ACS) with complex bifurcation lesions. Our previous ULTIMATE trial has demonstrated that IVUS-guided drug-eluting stent (DES) implantation significantly improved clinical outcome in all-comers, particularly for patients who had an IVUS-defined optimal procedure, compared with angiography guidance. However, the benefit of IVUS guidance in coronary severe calcification still remains unknown in the modern DES era.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
864

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
84mo left

Started Apr 2023

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Apr 2023Mar 2033

First Submitted

Initial submission to the registry

March 23, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

April 7, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2033

Expected
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

3 years

First QC Date

March 23, 2023

Last Update Submit

November 13, 2024

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • the rate of target-vessel failure at 12 months

    the composite of cardiovascular death, target-vessel myocardial infarction, and clinically driven target-vessel revascularization

    12 months after indexed procedure

Study Arms (2)

Intravascular ultrasound guidance

EXPERIMENTAL
Procedure: Intravascular ultrasound

Angiography guidance

ACTIVE COMPARATOR
Procedure: Angiography

Interventions

Intravascular ultrasoundPROCEDURE

Pretreatment strategy, stent size, stent landing zone and post-dilation balloon size are depended on intravascular ultrasound.

Intravascular ultrasound guidance
AngiographyPROCEDURE

Pretreatment strategy, stent size, stent landing zone and post-dilation balloon size are depended on angiography.

Angiography guidance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Silent ischemia, stable or unstable angina, non-ST-segment elevation myocardial infarction \> 48 hours, or ST-segment elevation myocardial infarction \> 7 days;
  • De novo coronary lesion eligible for drug-eluting stent implantation;
  • Target lesion with severe calcification;

You may not qualify if:

  • Age less than 18-year-old;
  • Comorbidity with a life expectancy \<12 months;
  • Intolerant of antithrombotic therapy;
  • Significant anemia, thrombocytopenia, or leucopenia;
  • History of major hemorrhage (intracranial, gastrointestinal, and so on);
  • Chronic total occlusion lesion not recanalized;
  • Scheduled major surgery in the next 12 months;
  • Left ventricular ejection fraction \< 25%;
  • Uremia dependent on dialysis treatment;
  • Previous drug-eluting stent implantation in target vessel;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ultrasonography, InterventionalCerebral Angiography

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeNeuroradiographyNeuroimagingAngiographyRadiographyDiagnostic Techniques, CardiovascularDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Shao-Liang Chen, MD

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun-Jie Zhang, MD

CONTACT

025-52271350jameszll@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice chief

Study Record Dates

First Submitted

March 23, 2023

First Posted

April 5, 2023

Study Start

April 7, 2023

Primary Completion

March 30, 2026

Study Completion (Estimated)

March 30, 2033

Last Updated

November 15, 2024

Record last verified: 2024-11

Locations

CN(1)