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
NCT ID: NCT02528474
Last Updated: 2019-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
24 participants
INTERVENTIONAL
2015-09-30
2017-04-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pantera Lux
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.
SeQuent Please
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, , South Korea
Countries
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Other Identifiers
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1-2015-0041
Identifier Type: -
Identifier Source: org_study_id
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