30
Participants
Start Date
August 20, 2020
Primary Completion Date
June 1, 2024
Study Completion Date
December 2, 2024
ABLUMINUS DES drug eluting stent
Following successful plain balloon angioplasty of the arterial lesion, (defined as \<30% residual stenosis after treatment at rated burst pressure of the angioplasty balloon), the ABLUMINUS stent will be deployed at the lesion as per Instructions for Use (IFU) after appropriate sizing using the diameter of the plain balloon angioplasty. After deployment of the ABLUMINUS stent, further balloon angioplasty of the stent will be performed, using the same diameter standard balloon catheter at 2 minutes inflation, to ensure adequate moulding and expansion of the stent.
RECRUITING
Sengkang General Hospital, Singapore
Lead Sponsor
Concept Medical Inc.
INDUSTRY