Multicenter LAser VA Registry of Percutaneous Coronary Interventions (LAVA)

• Conditions: Arteriosclerosis; Coronary Artery Disease; Laser-assisted Percutaneous Coronary Interventions
• Interventions: Procedure: Laser-assisted percutaneous coronary interventions

• Registration Number: NCT02789462
• Lead Sponsor: North Texas Veterans Healthcare System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-03-22
• Study First Submitted QC: 2016-05-27
• Study First Posted: 2016-06-03
• Primary Completion: 2017-03
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing laser-assisted PCI	Laser-assisted percutaneous coronary interventions	Patients of VAMC centers who undergone laser-assisted percutaneous coronary interventions.

Primary Outcome Measures

Name	Time	Method
Procedural success of the PCI	through hospital discharge post-PCI procedure, approximately 24 hours, but variable based on patient recovery.	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.

Secondary Outcome Measures

Name	Time	Method
Technical success of the PCI	through end of PCI of procedure, approximately 5 minutes after end of procedure	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.
major adverse cardiovascular events	through hospital discharge post-PCI procedure,approximately 24 hours, but variable based on patient recovery.	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.