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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

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.

Condition or disease Intervention/treatment Phase
CHD - Coronary Heart Disease Percutaneous Coronary Intervention In-stent Restenosis Procedure: Percutaneous Coronary Intervention under OCT Procedure: Percutaneous Coronary Intervention under Angiography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis: A Prospective Registry Trial
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : September 1, 2020

Arm Intervention/treatment
Experimental: OCT-guided PCI Procedure: Percutaneous Coronary Intervention under OCT
After randomization, subjects receive primary PCI under the guiding of OCT

Sham Comparator: Angiography-guided PCI Procedure: Percutaneous Coronary Intervention under Angiography
After randomization, subjects receive primary PCI under the guiding of angiography




Primary Outcome Measures :
  1. In-segment late loss at 9 months follow-up [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Rates of acute success [ Time Frame: 1 month ]
  2. Rate of 9-month binary restenosis [ Time Frame: 9 months ]
  3. Number of Participants with target lesion failure (TLF) [ Time Frame: 12 months ]
  4. Rate of major adverse cardiovascular events [ Time Frame: 12 months ]
  5. Number of participants with all-cause death [ Time Frame: 12 months ]
  6. Rate of myocardial infarction [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03809754


Contacts
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Contact: Yundai Chen +8601055499135 yundaichen@vip.163.com
Contact: Lei Gao nkgaolei2010@126.com

Locations
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China
Yundai Chen Not yet recruiting
Beijing, China
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Yundai Chen Chinese PLA General Hospital

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Responsible Party: Yun Dai Chen, Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03809754     History of Changes
Other Study ID Numbers: Z171100001017158
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases