Ignite Creation Date:
2024-05-06 @ 3:34 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02325869
Status:
UNKNOWN
Last Update Posted:
2015-07-28
First Post:
2014-12-22
Brief Title:
Clinical Study Protocol - Debris Interventional Removal in ACS DESIRE-ACS
Sponsor:
Angioslide Ltd
Organization:
Angioslide Ltd
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2015-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DESIRE-ACS
Brief 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 ie 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None