ULTIMATE IV: IVUS-guided DES Implantation in Coronary Calcification

Sponsor

Nanjing First Hospital, Nanjing Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05800002

Collaborator

(none)

864

Enrollment

Location

Arms

119.8

Anticipated Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
IVUS	Procedure: Intravascular ultrasound Procedure: Angiography	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

864 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 7, 2023

Anticipated Primary Completion Date :

Mar 30, 2026

Anticipated Study Completion Date :

Mar 30, 2033

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intravascular ultrasound guidance	Procedure: Intravascular ultrasound Pretreatment strategy, stent size, stent landing zone and post-dilation balloon size are depended on intravascular ultrasound.
Active Comparator: Angiography guidance	Procedure: Angiography Pretreatment strategy, stent size, stent landing zone and post-dilation balloon size are depended on angiography.

Arm

Intervention/Treatment

Experimental: Intravascular ultrasound guidance

Procedure: Intravascular ultrasound

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

Active Comparator: Angiography guidance

Procedure: Angiography

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

Outcome Measures

Primary Outcome Measures

the rate of target-vessel failure at 12 months [12 months after indexed procedure]
the composite of cardiovascular death, target-vessel myocardial infarction, and clinically driven target-vessel revascularization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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;

Exclusion Criteria:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanjing First Hospital	Nanjing	Jiangsu	China

Sponsors and Collaborators

Nanjing First Hospital, Nanjing Medical University

Investigators

Principal Investigator: Shao-Liang Chen, MD, The First Affiliated Hospital with Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Junjie Zhang, Vice chief, Nanjing First Hospital, Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT05800002

Other Study ID Numbers:

KY20230310-10

First Posted:

Apr 5, 2023

Last Update Posted:

Apr 11, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Calcinosis

Study Results

No Results Posted as of Apr 11, 2023