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

This study is currently recruiting participants.
Verified September 2017 by Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02215915
First Posted: August 13, 2014
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University
  Purpose
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.

Condition Intervention
Coronary Artery Disease Procedure: Angiography Procedure: IVUS Procedure: DES implantation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-comers" Coronary Lesions (ULTIMATE Trial)

Resource links provided by NLM:


Further study details as provided by Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University:

Primary Outcome Measures:
  • Target Vessel Failure [ Time Frame: 12 months ]
    The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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).


Estimated Enrollment: 1448
Actual Study Start Date: August 1, 2014
Estimated Study Completion Date: May 12, 2020
Estimated Primary Completion Date: May 12, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Shaoliang Chen, MD +86 13605157029 chmengx@126.com
Contact: Junjie Zhang, MD, PHD +86 18951670357 jameszll@163.com

Locations
China, Jiangsu
Nanjing First Hospital Recruiting
Nanjing, Jiangsu, China, 210006
Contact: Shaoliang Chen, MD    +86 13605157029    chmengx@126.com   
Principal Investigator: Shaoliang Chen, MD         
Sub-Investigator: Junjie Zhang, MD PHD         
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
Investigators
Principal Investigator: Shaoliang Chen, MD Nanjing First Hospital, Nanjing Medical University
  More Information

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     History of Changes
Other Study ID Numbers: 20140729
First Submitted: August 8, 2014
First Posted: August 13, 2014
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University:
Percutaneous coronary intervention
Drug-eluting stent
Intravascular ultrasound

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases