Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis
Primary Purpose
CHD - Coronary Heart Disease, Percutaneous Coronary Intervention, In-stent Restenosis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention under OCT
Percutaneous Coronary Intervention under Angiography
Sponsored by
About this trial
This is an interventional treatment trial for CHD - Coronary Heart Disease
Eligibility 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
Sites / Locations
- Yundai Chen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
OCT-guided PCI
Angiography-guided PCI
Arm Description
Outcomes
Primary Outcome Measures
In-segment late loss at 9 months follow-up
Secondary Outcome Measures
Rates of acute success
Rate of 9-month binary restenosis
Number of Participants with target lesion failure (TLF)
Rate of major adverse cardiovascular events
Number of participants with all-cause death
Rate of myocardial infarction
Full Information
NCT ID
NCT03809754
First Posted
January 15, 2019
Last Updated
January 21, 2019
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03809754
Brief Title
Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis
Official Title
Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis: A Prospective Registry Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CHD - Coronary Heart Disease, Percutaneous Coronary Intervention, In-stent Restenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OCT-guided PCI
Arm Type
Experimental
Arm Title
Angiography-guided PCI
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention under OCT
Intervention Description
After randomization, subjects receive primary PCI under the guiding of OCT
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention under Angiography
Intervention Description
After randomization, subjects receive primary PCI under the guiding of angiography
Primary Outcome Measure Information:
Title
In-segment late loss at 9 months follow-up
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Rates of acute success
Time Frame
1 month
Title
Rate of 9-month binary restenosis
Time Frame
9 months
Title
Number of Participants with target lesion failure (TLF)
Time Frame
12 months
Title
Rate of major adverse cardiovascular events
Time Frame
12 months
Title
Number of participants with all-cause death
Time Frame
12 months
Title
Rate of myocardial infarction
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yundai Chen
Phone
+8601055499135
Email
yundaichen@vip.163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Gao
Email
nkgaolei2010@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yundai Chen
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yundai Chen
City
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis
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