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

Not Applicable

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Device: balloon angioplasty with Pantera Lux; Device: balloon angioplasty with SeQuent Please

• Registration Number: NCT02528474
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-31
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Study Start: 2015-09-30
• Primary Completion: 2017-04-20
• Study Completion: 2017-04-20
• Status Verified: 2019-02
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pantera Lux	balloon angioplasty with Pantera Lux	-
SeQuent Please	balloon angioplasty with SeQuent Please	-

Primary Outcome Measures

Name	Time	Method
Neointimal thickness & area	9 months	measured by OCT analysis

Trial Locations

Locations (1)

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of