Arteriosclerosis, Coronary Artery Disease, Laser-assisted Percutaneous Coronary Interventions
Conditions
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.
Interventions
PROCEDURELaser-assisted percutaneous coronary interventions
Chart review and data collection of patients undergoing laser-assisted percutaneous coronary interventions
Sponsors
North Texas Veterans Healthcare System
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed