Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-comers" Coronary Lesions （ULTIMATE Trial）

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: IVUS; Procedure: Angiography; Procedure: DES implantation

• Registration Number: NCT02215915
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

A number of 1448 patients scheduled for elective percutaneous coronary intervention (PCI) with a native coronary stenosis suitable for DES implantation and IVUS imaging are openly randomized 1:1 to either IVUS guidance or angiographic guidance groups.

Detailed Description

The study is prospectively conducted at 8 high-volume PCI centers in China with IVUS expertise. Clinic follow-up are planned in all patients 12 months after implantation of drug eluting stents. Primary endpoint is target vessel failure. The study is powered for primary endpoint, which are likely to reach significance at the level P \< 0.05 even at a follow-up drop-out rate up to 10%.

Study Timeline

• Study Start: 2014-08-01
• Study First Submitted: 2014-08-08
• Study First Submitted QC: 2014-08-11
• Study First Posted: 2014-08-13
• Primary Completion: 2017-05-30
• Study Completion: 2020-10-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-01
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1448

Inclusion Criteria

• Provision of informed consent prior to any study specific procedures;
• Men and women 18 years and older;.
• Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology;
• Native coronary lesion suitable for drug-eluting stent placement and IVUS imaging.

Exclusion Criteria

• Pregnancy and breast feeding mother;
• Co-morbidity with an estimated life expectancy of < 50 % at 12 months;
• Scheduled major surgery in the next 12 months;
• Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
• Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days;
• Known allergy against ticagrelor, or against clopidogrel, or aspirin History of major hemorrhage (intracranial, gastrointestinal, etc.);
• Chronic total occlusion lesion in either LAD, or LCX or RCA not re-canalized;
• Severe calcification needing rotational atherectomy；
• Patient with STEMI (within 24-hour from the onset of chest pain to admission).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IVUS guided DES implantation	IVUS	Stent size and length were selected by online IVUS measurements, and adjunct high-pressure dilation was performed according to the discretion of operators based on the IVUS criteria for stent optimization.
IVUS guided DES implantation	DES implantation	Stent size and length were selected by online IVUS measurements, and adjunct high-pressure dilation was performed according to the discretion of operators based on the IVUS criteria for stent optimization.
Angiography guided DES implantation	Angiography	Stent size and length were chosen by visual estimation, and adjunct high-pressure dilation was performed if an optimal result was not achieved, which was defined as angiographic residual diameter stenosis 20% and absence of angiographically detected dissection.
Angiography guided DES implantation	DES implantation	Stent size and length were chosen by visual estimation, and adjunct high-pressure dilation was performed if an optimal result was not achieved, which was defined as angiographic residual diameter stenosis 20% and absence of angiographically detected dissection.

Primary Outcome Measures

Name	Time	Method
Target Vessel Failure	12 months	The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization.

Secondary Outcome Measures

Name	Time	Method
Mortality	12 months	the occurrence of 1-year all cause death
Cardiac death	12 months	Death that could not be attributed to a noncardiac etiology was considered cardiac death.
Myocardial infarction	12 months	Myocardial infarction was diagnosed by electrocardiographic changes and/or a rise and fall of creatine kinase-myocardial band fraction in the presence of ischemic symptoms.
Target vessel revascularization	12 months	Target vessel revascularization was defined as repeated revascularization by PCI or surgery of the target vessel.
Target lesion revascularization	12 months	Target lesion revascularization was defined as any revascularization procedure performed at the site of the treated lesion associated with clinical and/or objective evidence of inducible myocardial ischemia.

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China