Clinical Study Protocol - Debris Interventional Removal in ACS

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02325869
Study type	Interventional
Source	Angioslide Ltd.
Contact	Eran Vickus
Phone	+972 9 7904609
Email	eranv@angioslide.com
Status	Recruiting
Phase	N/A
Start date	July 2015
Completion date	March 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms