IVUS-guided DES Implantation in Coronary Calcification

Coronary Artery Disease Clinical Trial

— ULTIMATE IV  

Official title:

Intravascular Ultrasound Versus Angiography Guided Drug-eluting Stent Implantation for Patients With Coronary Severe Calcification: a Prospective, Multicenter, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05800002
• Other study ID #: KY20230310-10
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2023
• Est. completion date: March 30, 2033

Study information

• Verified date: April 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Jun-Jie Zhang, MD
• Phone: 025-52271350
• Email: jameszll[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 864
• Est. completion date: March 30, 2033
• Est. primary completion date: March 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• Intravascular ultrasound
Pretreatment strategy, stent size, stent landing zone and post-dilation balloon size are depended on intravascular ultrasound.
• Angiography
Pretreatment strategy, stent size, stent landing zone and post-dilation balloon size are depended on angiography.

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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