IVUS-guided DES Implantation in Coronary Calcification

NCT ID: NCT05800002

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 864 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-07
• Study Completion Date: 2033-03-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intravascular ultrasound guidance

Group Type: EXPERIMENTAL

Intravascular ultrasound

Intervention Type: PROCEDURE

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

Angiography guidance

Group Type: ACTIVE_COMPARATOR

Angiography

Intervention Type: PROCEDURE

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

Interventions

Intravascular ultrasound

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

Intervention Type: PROCEDURE

Angiography

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Silent ischemia, stable or unstable angina, non-ST-segment elevation myocardial infarction > 48 hours, or ST-segment elevation myocardial infarction > 7 days;

2. De novo coronary lesion eligible for drug-eluting stent implantation;

3. Target lesion with severe calcification;

Exclusion Criteria

1. Age less than 18-year-old;

2. Comorbidity with a life expectancy <12 months;

3. Intolerant of antithrombotic therapy;

4. Significant anemia, thrombocytopenia, or leucopenia;

5. History of major hemorrhage (intracranial, gastrointestinal, and so on);

6. Chronic total occlusion lesion not recanalized;

7. Scheduled major surgery in the next 12 months;

8. Left ventricular ejection fraction < 25%;

9. Uremia dependent on dialysis treatment;

10. Previous drug-eluting stent implantation in target vessel;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Junjie Zhang

Vice chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shao-Liang Chen, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun-Jie Zhang, MD

Role: CONTACT

jameszll@163.com

025-52271350

Facility Contacts

Shaoliang Chen, MD

Role: primary

chmengx@126.com

13605157029

Other Identifiers

KY20230310-10

Identifier Type: -

Identifier Source: org_study_id