Multicenter LAser VA Registry of Percutaneous Coronary Interventions (LAVA)

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, investigator initiated study that will prospectively and retrospectively examine treatment strategies and outcomes of patients who underwent percutaneous coronary interventions (PCI). The goal of this multi-center, investigator initiated, registry is to collect information on treatment strategies and outcomes of consecutive patients undergoing laser-assisted PCI among various participating centers. The study is a purely observational, chart review study and involves retrieval and compiling of data based on clinically indicated procedures and follow-up clinical and procedural outcomes. The information collected will be used to determine the frequency of laser-assisted PCI performed at the participating sites and examine the procedural strategies utilized, and the procedural (both immediate and subsequent) outcomes.

Official Title
-----------------
Multicenter LAser VA Registry of Percutaneous Coronary Interventions (LAVA)

Conditions
-----------------
Arteriosclerosis, Coronary Artery Disease, Laser-assisted Percutaneous Coronary Interventions

Intervention / Treatment
-----------------
* Procedure: Laser-assisted percutaneous coronary interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have undergone/will be undergoing laser-assisted PCI at each of the participating centers during the study period. Willing and able to provide informed consent. Exclusion Criteria: Not eligible candidate as per review by Investigator.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing laser-assisted PCI<br>Patients of VAMC centers who undergone laser-assisted percutaneous coronary interventions. | Procedure: Laser-assisted percutaneous coronary interventions<br>* Chart review and data collection of patients undergoing laser-assisted percutaneous coronary interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success of the PCI | Procedural success is defined as achievement of technical success with no in-hospital major adverse cardiac events (MACE). In-hospital MACE includes any of the following adverse events prior to hospital discharge: death from any cause, myocardial infarction, urgent repeat target vessel revascularization with PCI or coronary bypass surgery, tamponade requiring pericardiocentesis or surgery, or stroke. | through hospital discharge post-PCI procedure, approximately 24 hours, but variable based on patient recovery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success of the PCI | Technical success of the PCI was defined as successful revascularization with achievement of <30% residual diameter stenosis within the treated segment and restoration of TIMI grade 3 antegrade flow. | through end of PCI of procedure, approximately 5 minutes after end of procedure | 
| major adverse cardiovascular events | In-hospital major adverse cardiovascular events (MACE) include any of the following adverse events prior to hospital discharge: death from any cause, myocardial infarction, urgent repeat target vessel revascularization with PCI or coronary bypass surgery, tamponade requiring pericardiocentesis or surgery, or stroke. MACE during clinical follow-up include death, myocardial infarction, target lesion and target vessel revascularization. | through hospital discharge post-PCI procedure,approximately 24 hours, but variable based on patient recovery. |