January 15, 2019
|
January 18, 2019
|
January 23, 2019
|
March 1, 2019
|
March 1, 2020 (Final data collection date for primary outcome measure)
|
In-segment late loss at 9 months follow-up [ Time Frame: 9 months ]
|
Same as current
|
|
- 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 ]
|
Same as current
|
Not Provided
|
Not Provided
|
|
Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis
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Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis: A Prospective Registry Trial
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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.
|
Not Provided
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Interventional
|
Not Applicable
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Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
|
- CHD - Coronary Heart Disease
- Percutaneous Coronary Intervention
- In-stent Restenosis
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- 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
|
|
Not Provided
|
|
Unknown status
|
240
|
Same as current
|
September 1, 2020
|
March 1, 2020 (Final data collection date for primary outcome measure)
|
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
|
Sexes Eligible for Study: |
All |
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18 Years and older (Adult, Older Adult)
|
No
|
Contact information is only displayed when the study is recruiting subjects
|
China
|
|
|
NCT03809754
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Z171100001017158
|
Not Provided
|
Studies a U.S. FDA-regulated Drug Product: |
No |
Studies a U.S. FDA-regulated Device Product: |
No |
|
Plan to Share IPD: |
Undecided |
|
Yun Dai Chen, Chinese PLA General Hospital
|
Chinese PLA General Hospital
|
Not Provided
|
Principal Investigator: |
Yundai Chen |
Chinese PLA General Hospital |
|
Chinese PLA General Hospital
|
January 2019
|