Multicenter LAser VA Registry of Percutaneous Coronary Interventions (LAVA)

Coronary Artery Disease Clinical Trial

— LAVA  

Official title:

Multicenter LAser VA Registry of Percutaneous Coronary Interventions (LAVA)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02789462
• Other study ID #: 15075
• Status: Active, not recruiting
• Phase: N/A
• First received: March 22, 2016
• Last updated: September 12, 2017
• Start date: January 2015

Study information

• Verified date: September 2017
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Artery Disease
• Coronary Disease
• Laser-assisted Percutaneous Coronary Interventions
• Myocardial Ischemia

Intervention

Procedure:
• Laser-assisted percutaneous coronary interventions
Chart review and data collection of patients undergoing laser-assisted percutaneous coronary interventions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System

References & Publications (9)

Badr S, Ben-Dor I, Dvir D, Barbash IM, Kitabata H, Minha S, Pendyala LK, Loh JP, Torguson R, Pichard AD, Waksman R. The state of the excimer laser for coronary intervention in the drug-eluting stent era. Cardiovasc Revasc Med. 2013 Mar-Apr;14(2):93-8. doi: 10.1016/j.carrev.2012.12.008. Epub 2013 Jan 16. — View Citation

Boatman DM, Saeed B, Varghese I, Peters CT, Daye J, Haider A, Roesle M, Banerjee S, Brilakis ES. Prior coronary artery bypass graft surgery patients undergoing diagnostic coronary angiography have multiple uncontrolled coronary artery disease risk factors and high risk for cardiovascular events. Heart Vessels. 2009 Jul;24(4):241-6. doi: 10.1007/s00380-008-1114-1. Epub 2009 Jul 22. — View Citation

Christofferson RD, Lehmann KG, Martin GV, Every N, Caldwell JH, Kapadia SR. Effect of chronic total coronary occlusion on treatment strategy. Am J Cardiol. 2005 May 1;95(9):1088-91. — View Citation

Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. — View Citation

Fernandez JP, Hobson AR, McKenzie D, Shah N, Sinha MK, Wells TA, Levy TM, Swallow RA, Talwar S, O'Kane PD. Beyond the balloon: excimer coronary laser atherectomy used alone or in combination with rotational atherectomy in the treatment of chronic total occlusions, non-crossable and non-expansible coronary lesions. EuroIntervention. 2013 Jun 22;9(2):243-50. doi: 10.4244/EIJV9I2A40. — View Citation

Jeroudi OM, Alomar ME, Michael TT, El Sabbagh A, Patel VG, Mogabgab O, Fuh E, Sherbet D, Lo N, Roesle M, Rangan BV, Abdullah SM, Hastings JL, Grodin J, Banerjee S, Brilakis ES. Prevalence and management of coronary chronic total occlusions in a tertiary Veterans Affairs hospital. Catheter Cardiovasc Interv. 2014 Oct 1;84(4):637-43. doi: 10.1002/ccd.25264. Epub 2013 Nov 13. — View Citation

Mauri L, Hsieh WH, Massaro JM, Ho KK, D'Agostino R, Cutlip DE. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med. 2007 Mar 8;356(10):1020-9. Epub 2007 Feb 12. — View Citation

Niccoli G, Belloni F, Cosentino N, Fracassi F, Falcioni E, Roberto M, Panico RA, Mongiardo R, Porto I, Leone AM, Burzotta F, Trani C, Crea F. Case-control registry of excimer laser coronary angioplasty versus distal protection devices in patients with acute coronary syndromes due to saphenous vein graft disease. Am J Cardiol. 2013 Nov 15;112(10):1586-91. doi: 10.1016/j.amjcard.2013.07.015. Epub 2013 Aug 30. — View Citation

Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction, Jaffe AS, Apple FS, Galvani M, Katus HA, Newby LK, Ravkilde J, Chaitman B, Clemmensen PM, Dellborg M, Hod H, Porela P, Underwood R, Bax JJ, Beller GA, Bonow R, Van der Wall EE, Bassand JP, Wijns W, Ferguson TB, Steg PG, Uretsky BF, Williams DO, Armstrong PW, Antman EM, Fox KA, Hamm CW, Ohman EM, Simoons ML, Poole-Wilson PA, Gurfinkel EP, Lopez-Sendon JL, Pais P, Mendis S, Zhu JR, Wallentin LC, Fernández-Avilés F, Fox KM, Parkhomenko AN, Priori SG, Tendera M, Voipio-Pulkki LM, Vahanian A, Camm AJ, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Morais J, Brener S, Harrington R, Morrow D, Lim M, Martinez-Rios MA, Steinhubl S, Levine GN, Gibler WB, Goff D, Tubaro M, Dudek D, Al-Attar N. Universal definition of myocardial infarction. Circulation. 2007 Nov 27;116(22):2634-53. Epub 2007 Oct 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.