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 University

Status

Terminated

Conditions

Coronary Artery Disease

Treatments

Device: balloon angioplasty with Pantera Lux

Device: balloon angioplasty with SeQuent Please

Study type

Interventional

Funder types

Other

Identifiers

NCT02528474

1-2015-0041

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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