NCT02215915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,448

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

2.8 years

First QC Date

August 8, 2014

Last Update Submit

November 1, 2020

Conditions

Coronary Artery Disease

Keywords

Percutaneous coronary interventionDrug-eluting stentIntravascular ultrasound

Outcome Measures

Primary Outcomes (1)

  • Target Vessel Failure

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

    12 months

Secondary Outcomes (5)

  • Mortality

    12 months

  • Cardiac death

    12 months

  • Myocardial infarction

    12 months

  • Target vessel revascularization

    12 months

  • Target lesion revascularization

    12 months

Other Outcomes (1)

  • Stent thrombus

    12 months

Study Arms (2)

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.

Procedure: IVUSProcedure: DES implantation

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.

Procedure: AngiographyProcedure: DES implantation

Interventions

AngiographyPROCEDURE

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.

Angiography guided DES implantation
IVUSPROCEDURE

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.

Also known as: Intravascular ultrasound
IVUS guided DES implantation
DES implantationPROCEDURE
Also known as: Percutaneous coronary drug-eluting stents implantation
Angiography guided DES implantationIVUS guided DES implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Related Publications (4)

  • 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.

    PMID: 35861828DERIVED

  • 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.

    PMID: 33541535DERIVED

  • 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.

    PMID: 31116913DERIVED

  • 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.

    PMID: 30261237DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Cerebral AngiographyUltrasonography, Interventional

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

NeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAngiographyRadiographyDiagnostic Techniques, CardiovascularDiagnostic Techniques, NeurologicalInvestigative TechniquesUltrasonographyMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Shaoliang Chen, MD

    Nanjing First Hospital, Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiology and Cath Lab, Vice President of Nanjing First Hospital, Nanjing Medical University

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 13, 2014

Study Start

August 1, 2014

Primary Completion

May 30, 2017

Study Completion

October 30, 2020

Last Updated

November 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)