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OpenTrials
Completed

NCT Number: NCT02215915

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Other names: Intravascular ultrasound

DES Implantation

Procedure

Other names: Percutaneous coronary drug-eluting stents implantation

Primary outcomes

  1. Target Vessel Failure

    Time frame: 12 months

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

Secondary outcomes

  1. Mortality

    Time frame: 12 months

    the occurrence of 1-year all cause death

  2. Cardiac death

    Time frame: 12 months

    Death that could not be attributed to a noncardiac etiology was considered cardiac death.

  3. 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.

  4. Target vessel revascularization

    Time frame: 12 months

    Target vessel revascularization was defined as repeated revascularization by PCI or surgery of the target vessel.

  5. 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 outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Acronym: ULTIMATE

Important dates

Study start
2014
Primary completion
2017
Study completion
2020
First posted
Aug 13, 2014
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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