Intravascular Ultrasound Guided Drug Eluting Stent Implantation in "All-comers" Coronary Lesions

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by The First Hospital of Nanjing Medical University
Sponsor:
Information provided by (Responsible Party):
Shaoliang Chen, The First Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT02215915
First received: August 8, 2014
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

A number of 2516 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 Phase
Coronary Artery Disease
Procedure: Angiography
Procedure: IVUS
Procedure: DES implantation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Randomized Trial of Intravascular Ultrasound Guided Compared to Angiography Guided Drug Eluting Stent Implantation in "All-comers" Coronary Lesions

Resource links provided by NLM:


Further study details as provided by The First Hospital of Nanjing Medical University:

Primary Outcome Measures:
  • Major adverse cardiac events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The occurrence of cardiac death and/or myocardial infraction.


Secondary Outcome Measures:
  • Mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    the occurrence of 1-year all cause death

  • Cardiac death [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Death that could not be attributed to a noncardiac etiology was considered cardiac death.

  • Myocardial infarction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Target vessel revascularization was defined as repeated revascularization by PCI or surgery of the target vessel.

  • Target lesion revascularization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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: 2516
Study Start Date: July 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (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
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 Procedure: DES implantation
Other Name: Percutaneous coronary drug-eluting stents implantation

Detailed Description:

The study is prospectively conducted at 6 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 composite of cardiac death and myocardial infraction. The study is powered for primary endpoint, which are likely to reach significance at the level P < 0.01 even at a follow-up drop-out rate up to 10%.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
The First Hospital of Nanjing Medical University
Investigators
Principal Investigator: Shaoliang Chen, MD Nanjing First Hospital, Nanjing Medical University
  More Information

No publications provided

Responsible Party: Shaoliang Chen, vice President, The First Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02215915     History of Changes
Other Study ID Numbers: 20140729
Study First Received: August 8, 2014
Last Updated: August 18, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by The First Hospital of 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

ClinicalTrials.gov processed this record on September 18, 2014