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

Study Overview
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Brief Summary
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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.

Official Title
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Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis: A Prospective Registry Trial

Conditions
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CHD - Coronary Heart Disease, Percutaneous Coronary Intervention, In-stent Restenosis

Intervention / Treatment
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* Procedure: Percutaneous Coronary Intervention under OCT
* Procedure: Percutaneous Coronary Intervention under Angiography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCT-guided PCI<br> | Procedure: Percutaneous Coronary Intervention under OCT<br>* After randomization, subjects receive primary PCI under the guiding of OCT<br>|
| Sham Comparator: Angiography-guided PCI<br> | Procedure: Percutaneous Coronary Intervention under Angiography<br>* After randomization, subjects receive primary PCI under the guiding of angiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment late loss at 9 months follow-up |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of acute success |  | 1 month | 
| Rate of 9-month binary restenosis |  | 9 months | 
| Number of Participants with target lesion failure (TLF) |  | 12 months | 
| Rate of major adverse cardiovascular events |  | 12 months | 
| Number of participants with all-cause death |  | 12 months | 
| Rate of myocardial infarction |  | 12 months |