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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02528474
• Other study ID #: 1-2015-0041
• Status: Terminated
• Phase: N/A
• Start date: September 30, 2015
• Est. completion date: April 20, 2017

Study information

• Verified date: February 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: April 20, 2017
• Est. primary completion date: April 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• 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 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.

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neointimal thickness & area	measured by OCT analysis	9 months