A Randomized Trial Comparing the Agent Paclitaxel-Coated PTCA Balloon Catheter vs SeQuent Please Drug Eluting Balloon Catheter for the Treatment of a Small Vessel De Novo Native Coronary Artery Lesion.
Primary objective is to evaluate the safety and effectiveness of the Agent ™ Paclitaxel-Coated PTCA Balloon Catheter for the treatment of Japanese subjects with a small vessel de novo native atherosclerotic coronary artery lesion or in-stent restenosis (ISR) of a previously treated lesion. Primary endpoint: Target Lesion Failure (TLF) rate at 6 months post index-procedure. TLF is defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
Percutaneous Transluminal Coronary Angioplasty
Percutaneous Transluminal Coronary Angioplasty
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, Japan
Japan Labour Health and Welfare Organization Kanto Rosai Hospital
Percentage of Participants With Events Included in the Primary Endpoint (Target Lesion Failure)
TLF is defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
Time frame: 6 months post procedure
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Saiseikai Yokohama-City Eastern Hospital
Yokohama, Kanagawa, Japan
Kyoto-Katsura Hospital
Kyoto, Kyoto, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Miyazaki Medical Association Hospital
Miyazaki, Miyazaki, Japan
Osaka Saiseikai Nakatsu Hospital
Kita, Osaka, Japan
Sakurabashi Watanabe Advanced Healthcare Hospital
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...and 4 more locations