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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Angiography
IVUS
DES implantation
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Percutaneous coronary intervention, Drug-eluting stent, Intravascular ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Nanjing First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IVUS guided DES implantation

Angiography guided DES implantation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Target Vessel Failure
The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization.

Secondary Outcome Measures

Mortality
the occurrence of 1-year all cause death
Cardiac death
Death that could not be attributed to a noncardiac etiology was considered cardiac death.
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.
Target vessel revascularization
Target vessel revascularization was defined as repeated revascularization by PCI or surgery of the target vessel.
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.

Full Information

First Posted
August 8, 2014
Last Updated
November 1, 2020
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02215915
Brief Title
Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-comers" Coronary Lesions （ULTIMATE Trial）
Acronym
ULTIMATE
Official Title
Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-comers" Coronary Lesions （ULTIMATE Trial）
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Percutaneous coronary intervention, Drug-eluting stent, Intravascular ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1448 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IVUS guided DES implantation
Arm Type
Experimental
Arm Description
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.
Arm Title
Angiography guided DES implantation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Angiography
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
IVUS
Other Intervention Name(s)
Intravascular ultrasound
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
DES implantation
Other Intervention Name(s)
Percutaneous coronary drug-eluting stents implantation
Primary Outcome Measure Information:
Title
Target Vessel Failure
Description
The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Mortality
Description
the occurrence of 1-year all cause death
Time Frame
12 months
Title
Cardiac death
Description
Death that could not be attributed to a noncardiac etiology was considered cardiac death.
Time Frame
12 months
Title
Myocardial infarction
Description
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.
Time Frame
12 months
Title
Target vessel revascularization
Description
Target vessel revascularization was defined as repeated revascularization by PCI or surgery of the target vessel.
Time Frame
12 months
Title
Target lesion revascularization
Description
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.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Stent thrombus
Description
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).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaoliang Chen, MD
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35861828
Citation
Lee SY, Zhang JJ, Mintz GS, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Kan J, Pan T, Gao X, Ge Z, Chen SL, Hong MK. Procedural Characteristics of Intravascular Ultrasound-Guided Percutaneous Coronary Intervention and Their Clinical Implications. J Am Heart Assoc. 2022 Jul 19;11(14):e025258. doi: 10.1161/JAHA.122.025258. Epub 2022 Jul 15.
Results Reference
derived
PubMed Identifier
33541535
Citation
Gao XF, Ge Z, Kong XQ, Kan J, Han L, Lu S, Tian NL, Lin S, Lu QH, Wang XY, Li QH, Liu ZZ, Chen Y, Qian XS, Wang J, Chai DY, Chen CH, Pan T, Ye F, Zhang JJ, Chen SL; ULTIMATE Investigators. 3-Year Outcomes of the ULTIMATE Trial Comparing Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation. JACC Cardiovasc Interv. 2021 Feb 8;14(3):247-257. doi: 10.1016/j.jcin.2020.10.001. Epub 2020 Oct 29.
Results Reference
derived
PubMed Identifier
31116913
Citation
Zhang J, Gao X, Ge Z, Han L, Lu S, Qian X, Li Q, Lu Q, Chen C, Chen SL; ULTIMATE Investigators. Impact of intravascular ultrasound-guided drug-eluting stent implantation on patients with chronic kidney disease: Results from ULTIMATE trial. Catheter Cardiovasc Interv. 2019 Jun 1;93(7):1184-1193. doi: 10.1002/ccd.28308. Epub 2019 May 22.
Results Reference
derived
PubMed Identifier
30261237
Citation
Zhang J, Gao X, Kan J, Ge Z, Han L, Lu S, Tian N, Lin S, Lu Q, Wu X, Li Q, Liu Z, Chen Y, Qian X, Wang J, Chai D, Chen C, Li X, Gogas BD, Pan T, Shan S, Ye F, Chen SL. Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation: The ULTIMATE Trial. J Am Coll Cardiol. 2018 Dec 18;72(24):3126-3137. doi: 10.1016/j.jacc.2018.09.013. Epub 2018 Sep 24.
Results Reference
derived

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

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