ABLUMINUS DES BTK Registry - FIM

NAUnknownINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 20, 2020

Primary Completion Date

June 1, 2024

Study Completion Date

December 2, 2024

Conditions
Peripheral Artery DiseaseArterial Disease of LegsAtherosclerosis
Interventions
DEVICE

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.

Trial Locations (1)

544886

RECRUITING

Sengkang General Hospital, Singapore

Sponsors
All Listed Sponsors
lead

Concept Medical Inc.

INDUSTRY