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

Coronary Artery Disease Clinical Trial

— ULTIMATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02215915
• Other study ID #: 20140729
• Status: Completed
• Phase: N/A
• Start date: August 1, 2014
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2020
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1448
• Est. completion date: October 30, 2020
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• Angiography
The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. Additional stent implantation or post dilation will be allowed according to attending physician's discrete. IVUS will be not used in this arm.
• IVUS
The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. IVUS will be used to assess the anatomic characteristics of lesion and determine appropriate stent size and length. Additional stent implantation or post dilation will be allowed according to attending physician's discrete based on IVUS results.
• DES implantation

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
Other	Stent thrombus	Stent thrombus was classified as definite, probable, or possible, according to the definitions provided by the Academic Research Consortium (ARC).Regarding timing, ST was defined as early (<30 days), late (30 days to 1 year), or too late (>1 year).	12 months
Primary	Target Vessel Failure	The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization.	12 months
Secondary	Mortality	the occurrence of 1-year all cause death	12 months
Secondary	Cardiac death	Death that could not be attributed to a noncardiac etiology was considered cardiac death.	12 months
Secondary	Myocardial infarction	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.	12 months
Secondary	Target vessel revascularization	Target vessel revascularization was defined as repeated revascularization by PCI or surgery of the target vessel.	12 months
Secondary	Target lesion revascularization	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.	12 months