Back to resultsComparison 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
Primary Purpose
Coronary Artery Disease
Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
balloon angioplasty with Pantera Lux
balloon angioplasty with SeQuent Please
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
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
Sites / Locations
- Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pantera Lux
SeQuent Please
Arm Description
Outcomes
Primary Outcome Measures
Neointimal thickness & area
measured by OCT analysis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02528474
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
As it is difficult to recruit any more subjects, the investigators decided to terminate the study.
Study Start Date
September 30, 2015 (undefined)
Primary Completion Date
April 20, 2017 (Actual)
Study Completion Date
April 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pantera Lux
Arm Type
Experimental
Arm Title
SeQuent Please
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
balloon angioplasty with Pantera Lux
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
balloon angioplasty with SeQuent Please
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neointimal thickness & area
Description
measured by OCT analysis
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
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
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