279
Participants
Start Date
September 8, 2020
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2026
MagicTouch PTA sirolimus drug coated balloon (DCB)
For participants randomised to MagicTouch PTA sirolimus DCB, following successful plain balloon angioplasty of the arterial lesion, (defined as \<30% residual stenosis after treatment at rated burst pressure of the angioplasty balloon), MagicTouch PTA sirolimus coated balloon will be applied at the lesion after appropriate sizing using the diameter of the plain balloon angioplasty.
POBA standard balloon
For participants randomised to the standard balloon angioplasty group, a placebo standard balloon which is identical to the SCB will also be applied at the lesion after appropriate sizing using the diameter of the plain balloon angioplasty.
RECRUITING
Khoo Teck Puat Hospital, Singapore
RECRUITING
National University Hospital, Singapore
NOT_YET_RECRUITING
Ng Teng Fong General Hospital, Singapore
RECRUITING
Sengkang General Hospital, Singapore
RECRUITING
Singapore General Hospital, Singapore
RECRUITING
Tan Tock Seng Hospital, Singapore
RECRUITING
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City
RECRUITING
Kaoshiung Chang Gung Memorial Hospital, Kaohsiung City
RECRUITING
Far Eastern Memorial Hospital, New Taipei City
RECRUITING
Taipei Tzuchi Hospital, New Taipei City
NOT_YET_RECRUITING
China Medical University Hospital, Taichung
RECRUITING
National Taiwan University Hospital, Taipei
RECRUITING
Shin Kong Wu Ho-Su Memorial Hospital, Taipei
RECRUITING
Linkou Chang Gung Memorial Hospital, Taoyuan
RECRUITING
Phramongkutklao Hospital, Bangkok
RECRUITING
Rajavithi Hospital, Bangkok
NOT_YET_RECRUITING
Ramathibodi Hospital, Bangkok
RECRUITING
Siriraj Hospital, Bangkok
RECRUITING
Vajira Hospital, Bangkok
RECRUITING
Thammasat University Hospital, Pathum Thani
Lead Sponsor
Concept Medical Inc.
INDUSTRY