Clinical trial NCT02215915: Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-comers" Coronary Lesions （ULTIMATE Trial）
Official title: Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-comers" Coronary Lesions （ULTIMATE Trial）
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Percutaneous coronary intervention
Drug-eluting stent
Intravascular ultrasound
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 1448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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).

Primary outcomes:
measure: Target Vessel Failure
timeFrame: 12 months
Secondary outcomes:
measure: Mortality
timeFrame: 12 months
measure: Cardiac death
timeFrame: 12 months
measure: Myocardial infarction
timeFrame: 12 months
measure: Target vessel revascularization
timeFrame: 12 months
measure: Target lesion revascularization
timeFrame: 12 months
Other outcomes:
measure: Stent thrombus
timeFrame: 12 months
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Shaoliang Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.