NCT02325869

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

DebriS Interventional REmoval in ACS (DESIRE-ACS) Study to Assess the Safety and Performance of the ECA Bell Balloon in Subjects Undergoing Coronary Percutaneous Interventions.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Angioslide Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

DebriS Interventional REmoval in ACS (DESIRE-ACS) Study to assess the safety and performance of the ECA Bell balloon in subjects undergoing coronary percutaneous interventions.

Detailed description

Coronary arterial disease (CAD) is defined as obstruction of blood flow into the coronary arteries (i.e. the arteries that supply blood to the heart muscle). Patients with symptoms of coronary artery disease usually suffer from stable angina pectoris (chest pain or discomfort), unstable angina pectoris, or a myocardial infarction (heart attack). The symptoms range from mild angina, to moderate or severe angina. In some cases of CAD the blood vessel is chronically totally blocked (total occlusion), stopping blood flow through the blocked blood vessel. In these cases a minimally invasive treatment or a surgery may be needed. "Minimally invasive procedures" consist of angioplasty or stent placement. The procedure is performed under local anesthetic with the patient lying on their back. Angioplasty is a routine, well known, non-surgical procedure that is performed by making a small incision of the skin in the groin through which a catheter (narrow tube) and a guidewire (a thin metal wire) are inserted to reach the blocked artery. After reaching the blocked artery and crossing the blockage with a guidewire, a tiny balloon is inflated inside the artery to open the blockage. During the course of this procedure small pieces of the material that is causing the blockage may break off and be carried by the blood stream to other parts of the body where they may lodge and cause damage by blocking the blood flow . The Bell Balloon Catheter is designed to help the physician capture some of this material that may have broken off.

Conditions

• Coronary Disease
• Acute Coronary Syndrome
• Coronary Occlusion

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-12-01
• Completion: 2016-03-01
• First posted: 2014-12-25
• Last updated: 2015-07-28

Locations

1 site across 1 country: Israel