Clinical Study Protocol - Debris Interventional Removal in ACS (DESIRE-ACS)

NAUnknownINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

December 31, 2015

Study Completion Date

March 31, 2016

Conditions
Coronary DiseaseAcute Coronary SyndromeCoronary Occlusion
Interventions
DEVICE

Bell Balloon Catheter

An angioplasty procedure to open the blockage in blood vessels will be performed. Standard angioplasty procedure includes local analgesia of the groin area and a small cut through which the procedure will be performed. An introducer sheath (thin tube) will be inserted. The Bell Balloon dilatation will then be inserted. The Bell Balloon works in fashion similar to standard balloon with the same physical and behavioral characteristics. Upon deflation, debris from the blockage is withdrawn into the cavity formed between the deflated balloon and its outer capsule. Then balloon is retracted and retrieved through the guiding catheter, together with the captured debris and trap it between the outer surface of the balloon and the inner surface of the membrane.

Trial Locations (1)

9103102

RECRUITING

Shaare Zedek Medical Center, Jerusalem

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Angioslide Ltd.

INDUSTRY

NCT02325869 - Clinical Study Protocol - Debris Interventional Removal in ACS (DESIRE-ACS) | Biotech Hunter | Biotech Hunter