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

Yonsei University24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

balloon angioplasty with Pantera Lux

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.

balloon angioplasty with SeQuent PleaseDEVICE

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes