Coronary Artery Disease
Conditions
Brief summary
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.
Interventions
DEVICEballoon 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.
DEVICEballoon angioplasty with SeQuent Please
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neointimal thickness & area | 9 months | measured by OCT analysis |
Countries
South Korea
Outcome results
None listed