Acute Coronary Syndrome Clinical Trial
Official title:
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.
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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