Multicenter LAser VA Registry of Percutaneous Coronary Interventions (LAVA) (LAVA)

September 12, 2017 updated by: Bavana V. Rangan, North Texas Veterans Healthcare System

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Potential subjects may or may not be patients of each site investigator and they will have undergone clinically indicated laser-assisted PCI at the investigator's site.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing laser-assisted PCI
Patients of VAMC centers who undergone laser-assisted percutaneous coronary interventions.
Procedure: Laser-assisted percutaneous coronary interventions
Chart review and data collection of patients undergoing laser-assisted percutaneous coronary interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural success of the PCI
Time Frame: 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.
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
Time Frame: 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.
through end of PCI of procedure, approximately 5 minutes after end of procedure
major adverse cardiovascular events
Time Frame: 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.
through hospital discharge post-PCI procedure,approximately 24 hours, but variable based on patient recovery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Texas Veterans Healthcare System

Investigators

  • Principal Investigator: Bavana Rangan, BDS, MPH, UT Southwestern Medical Center/ Dallas VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

March 22, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (ESTIMATE)

June 3, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15075

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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