Comparison of Optical Coherence Tomographic Findings After Balloon Angioplasty With Two Different Paclitaxel-Coated Balloons for the Treatment of In-Stent Restenosis in Drug-Eluting Stents

Study Overview
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Brief Summary
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Drug-coated balloon technology (DCB) has recently attracted considerable interest as a promising alternative treatment option, particularly in the setting of in-stent restenosis (ISR). Optical coherence tomographic finding of restenosis lesions in drug-eluting stents (DESs) after Balloon Angioplasty with Two Different Paclitaxel-Coated Balloons will be compared between two paclitaxel-coated balloon devices; Pantera Lux™ and SeQuent® Please.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: balloon angioplasty with Pantera Lux
* Device: balloon angioplasty with SeQuent Please


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 19 years old Patients eligible for percutaneous coronary intervention Single or more lesion(s) of restenosis requiring angioplasty in drug-eluting stent Reference vessel diameter of target lesion ≥2.5 mm Exclusion Criteria: Cardiogenic shock Bifurcation lesion or totally occluded lesion Unprotected left main trunk lesion Allergies or hypersensitivities to antiplatelet, anticoagulation therapy, contrast media, or paclitaxel Heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesions Pregnant women or women with potential childbearing Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator Inability to understand or read the informed content

Ages Eligible for Study
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Minimum Age: 19 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pantera Lux<br> | Device: balloon angioplasty with Pantera Lux<br>* Patient will be considered to be enrolled if ISR in DES was found by angiography. After randomization, patients will be treated with Pantera Lux for treatment of ISR. OCT will be performed just after balloon angioplasty for ISR lesion. Information will be collected and recorded on the treated study vessel including angiographic and OCT parameters. Follow-up OCT at 9 month will be performed.<br>|
| Active Comparator: SeQuent Please<br> | Device: balloon angioplasty with SeQuent Please<br>* Patient will be considered to be enrolled if ISR in DES was found by angiography. After randomization, patients will be treated with SeQuent Please for treatment of ISR. OCT will be performed just after balloon angioplasty for ISR lesion. Information will be collected and recorded on the treated study vessel including angiographic and OCT parameters. Follow-up OCT at 9 month will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neointimal thickness & area | measured by OCT analysis | 9 months |