OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery

Study Overview
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Brief Summary
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OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter cohort study aims to assess the efficacy and safety of OCT- versus angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery after lesion preparation with scoring balloon.

Official Title
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OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery After Lesion Preparation With Scoring Balloon - A Prospective Multicenter Cohort Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: OCT-guided paclitaxel drug-coated balloon angioplasty
* Device: Angiography-guided paclitaxel drug-coated balloon angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 85 years old Patients have ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of a stenosis of at least 50% in a native coronary artery, including stable angina, unstable angina, or silent ischemia. Reference vessel diameter >2.5 mm, and <4.0 mm. Lesion length of <22 mm Written informed consent Exclusion Criteria: Myocardial infarction within 4 weeks, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction Cardiogenic shock (systolic arterial pressure <90mmHg), congestive heart failure (NYHA or Killip≥3) Chronic kidney disease (eGFR <30 ml/min) Lesion length >22 mm, or vessel diameters of <2.5 mm or >4.0 mm Stents covering a major side branch (>2 mm) Left main lesion Graft lesion Aortic-coronary ostial lesion In-stent restenotic lesion Chronic total occlusion Severe calcified lesions. Visible angiographic thrombus Severe comorbidities: eg. malignancy (life expectancy <2 years)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OCT-guided arm<br> | Device: OCT-guided paclitaxel drug-coated balloon angioplasty<br>* OCT-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery<br>|
| Placebo Comparator: Angiography-guided arm<br> | Device: Angiography-guided paclitaxel drug-coated balloon angioplasty<br>* Angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late lumen loss | Evaluated by QCA | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of binary restenosis | Evaluated by QCA | 9 months | 
| Target lesion failure | Including death, target vessel myocardial infarction, or target lesion revascularization | 9 months |