Balloon Pump Assisted Coronary Intervention Study

Study Overview
=================
Brief Summary
-----------------
This study will test the hypothesis that elective use of the Intra-Aortic Balloon Pump (IABP) in patients undergoing high-risk Percutaneous Coronary Intervention (PCI) will reduce the rate of in-hospital major adverse cardiac and cerebrovascular events compared to patients who are managed without planned insertion of IABP.

Official Title
-----------------
Balloon Pump Assisted Coronary Intervention Study

Conditions
-----------------
Coronary Artery Disease, Left Ventricular Dysfunction

Intervention / Treatment
-----------------
* Device: Intra-Aortic Balloon Pump


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: impaired left ventricular function (Ejection Fraction < 30%) large area of myocardium at risk (BCIS-1 Myocardial Jeopardy Score ≥ 8/12) Exclusion Criteria: cardiogenic shock acute STEMI within previous 48 hours complications of recent AMI (including ventricular septal defect, severe mitral regurgitation, intractable ventricular arrhythmias) contraindications to IABP use (including significant iliac or femoral arterial disease and more than mild aortic regurgitation)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elective IABP Insertion<br> | Device: Intra-Aortic Balloon Pump<br>* Elective IABP insertion before PCI<br>|
| No Intervention: No Planned IABP Insertion<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac and Cerebrovascular Events | (composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event) | Hospital discharge or 28 days following PCI, whichever occurs sooner | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Mortality |  | 6-months following randomization | 
| Major Procedural Complications |  | Duration of PCI procedure | 
| Bleeding Complications (Major and Minor) |  | Hospital Discharge or 28 days following PCI (whichever occurs sooner) | 
| Access Site Complications |  | Hospital Discharge or 28 days following PCI (whichever occurs sooner) | 
| Transient Ischemic Attack |  | Hospital Discharge or 28 days following PCI (whichever occurs sooner) | 
| Length of Hospital Stay |  | Hospital Discharge | 
| Procedural Success |  | Duration of PCI procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery Disease, Percutaneous Transluminal Coronary Angioplasty, Intraaortic Balloon Pumping, Left Ventricular Dysfunction, High Risk