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Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis

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ClinicalTrials.gov Identifier: NCT03809754
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Yun Dai Chen, Chinese PLA General Hospital

Tracking Information
First Submitted Date  ICMJE January 15, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date January 23, 2019
Estimated Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
In-segment late loss at 9 months follow-up [ Time Frame: 9 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03809754 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • Rates of acute success [ Time Frame: 1 month ]
  • Rate of 9-month binary restenosis [ Time Frame: 9 months ]
  • Number of Participants with target lesion failure (TLF) [ Time Frame: 12 months ]
  • Rate of major adverse cardiovascular events [ Time Frame: 12 months ]
  • Number of participants with all-cause death [ Time Frame: 12 months ]
  • Rate of myocardial infarction [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis
Official Title  ICMJE Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis: A Prospective Registry Trial
Brief Summary This study is a prospective, registry trial aimed to compare the clinical and angiographic outcomes of OCT-guided and angiography-guided PCI in patients with coronary DES-ISR.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • CHD - Coronary Heart Disease
  • Percutaneous Coronary Intervention
  • In-stent Restenosis
Intervention  ICMJE
  • Procedure: Percutaneous Coronary Intervention under OCT
    After randomization, subjects receive primary PCI under the guiding of OCT
  • Procedure: Percutaneous Coronary Intervention under Angiography
    After randomization, subjects receive primary PCI under the guiding of angiography
Study Arms  ICMJE
  • Experimental: OCT-guided PCI
    Intervention: Procedure: Percutaneous Coronary Intervention under OCT
  • Sham Comparator: Angiography-guided PCI
    Intervention: Procedure: Percutaneous Coronary Intervention under Angiography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 17, 2019)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 years or older
  • Patients with angina or evidence of myocardial ischaemia
  • Patients with restenotic lesions in a previously DES area of a coronary artery
  • Patients suitable to receive any types of percutaneous coronary intervention (including balloon angioplasty and stent implantation)
  • The stent diameter of DES-ISR is 2.5mm to 4.0mm
  • Target lesion length < 30mm
  • Target lesion stenosis ≥ 70% diameter stenosis on visual assessment, or ≥ 50% diameter stenosis and with evidence of myocardial ischaemia ischemic

Exclusion Criteria:

  • Patients with acute myocardial infarction with 1 week
  • Patients with evidence of extensive thrombosis in the target vessel
  • Patients with left main coronary artery disease
  • Patients with cardiogenic shock, left ventricular ejection fraction < 40%,significant renal dysfunction and severe heart valve disease
  • Patients who had cerebral stroke within 6 months before PCI
  • Patients with a life expectancy < 1 year
  • Patients not able to adhere to follow-up visits
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yundai Chen +8601055499135 yundaichen@vip.163.com
Contact: Lei Gao nkgaolei2010@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809754
Other Study ID Numbers  ICMJE Z171100001017158
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yun Dai Chen, Chinese PLA General Hospital
Study Sponsor  ICMJE Chinese PLA General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yundai Chen Chinese PLA General Hospital
PRS Account Chinese PLA General Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP