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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.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVUS guided DES implantation | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiography | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Target Vessel Failure | The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | the occurrence of 1-year all cause death | 12 months |
| Cardiac death | Death that could not be attributed to a noncardiac etiology was considered cardiac death. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaoliang Chen, MD | Nanjing First Hospital, Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital | Nanjing | Jiangsu | 210006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35861828 | Derived | 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. | |
| 33541535 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D002533 | Cerebral Angiography |
| D018084 | Ultrasonography, Interventional |
| ID | Term |
|---|---|
| D009485 | Neuroradiography |
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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|
| IVUS | Procedure | 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 | Procedure |
|
|
| 12 months |
| 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 |
| Target vessel revascularization | Target vessel revascularization was defined as repeated revascularization by PCI or surgery of the target vessel. | 12 months |
| 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 |
| 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. |
| 31116913 | Derived | 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. |
| 30261237 | Derived | 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D003933 |
| Diagnosis |
| D000792 | Angiography |
| D011859 | Radiography |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |
| D014463 | Ultrasonography |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |