Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-comers" Coronary Lesions (ULTIMATE Trial) (ULTIMATE)
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ClinicalTrials.gov Identifier: NCT02215915 |
Recruitment Status :
Completed
First Posted : August 13, 2014
Last Update Posted : November 3, 2020
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Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Disease | Procedure: Angiography Procedure: IVUS Procedure: DES implantation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1448 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-comers" Coronary Lesions (ULTIMATE Trial) |
Actual Study Start Date : | August 1, 2014 |
Actual Primary Completion Date : | May 30, 2017 |
Actual Study Completion Date : | October 30, 2020 |
Arm | Intervention/treatment |
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Experimental: IVUS guided 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.
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Procedure: 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.
Other Name: Intravascular ultrasound Procedure: DES implantation Other Name: Percutaneous coronary drug-eluting stents implantation |
Active Comparator: Angiography guided 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.
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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. Procedure: DES implantation Other Name: Percutaneous coronary drug-eluting stents implantation |
- Target Vessel Failure [ Time Frame: 12 months ]The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization.
- Mortality [ Time Frame: 12 months ]the occurrence of 1-year all cause death
- Cardiac death [ Time Frame: 12 months ]Death that could not be attributed to a noncardiac etiology was considered cardiac death.
- Myocardial infarction [ Time Frame: 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 [ Time Frame: 12 months ]Target vessel revascularization was defined as repeated revascularization by PCI or surgery of the target vessel.
- Target lesion revascularization [ Time Frame: 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.
- Stent thrombus [ Time Frame: 12 months ]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).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215915
China, Jiangsu | |
Nanjing First Hospital | |
Nanjing, Jiangsu, China, 210006 |
Principal Investigator: | Shaoliang Chen, MD | Nanjing First Hospital, Nanjing Medical University |
Responsible Party: | Shaoliang Chen, Director of Cardiology and Cath Lab, Vice President of Nanjing First Hospital, Nanjing Medical University, Nanjing First Hospital, Nanjing Medical University |
ClinicalTrials.gov Identifier: | NCT02215915 |
Other Study ID Numbers: |
20140729 |
First Posted: | August 13, 2014 Key Record Dates |
Last Update Posted: | November 3, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Percutaneous coronary intervention Drug-eluting stent Intravascular ultrasound |
Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |