Multicenter LAser VA Registry of Percutaneous Coronary Interventions (LAVA)

NCT02789462 | Unknown

• 1 other identifier: 15075
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arteriosclerosis; Coronary Artery Disease; Laser-assisted Percutaneous Coronary Interventions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Technical success of the PCI

  through end of PCI of procedure, approximately 5 minutes after end of procedure

• major adverse cardiovascular events

  through hospital discharge post-PCI procedure,approximately 24 hours, but variable based on patient recovery.

Study Arms (1)

Patients undergoing laser-assisted PCI

Patients of VAMC centers who undergone laser-assisted percutaneous coronary interventions.

Procedure: Laser-assisted percutaneous coronary interventions

Interventions

Laser-assisted percutaneous coronary interventions PROCEDURE

Chart review and data collection of patients undergoing laser-assisted percutaneous coronary interventions

Patients undergoing laser-assisted PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Not eligible candidate as per review by Investigator.

Sponsors & Collaborators

• North Texas Veterans Healthcare System: lead

Related Publications (9)

• 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.

  PMID: 24142769 BACKGROUND

• 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. doi: 10.1016/j.amjcard.2004.12.065.

  PMID: 15842978 BACKGROUND

• 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.

  PMID: 19626394 BACKGROUND

• 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.

  PMID: 23993124 BACKGROUND

• 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.

  PMID: 23454891 BACKGROUND

• 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.

  PMID: 23332778 BACKGROUND

• 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. doi: 10.1056/NEJMoa067731. Epub 2007 Feb 12.

  PMID: 17296821 BACKGROUND

• 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. doi: 10.1161/CIRCULATIONAHA.106.685313.

  PMID: 17470709 BACKGROUND

• 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, Fernandez-Aviles 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. doi: 10.1161/CIRCULATIONAHA.107.187397. Epub 2007 Oct 19. No abstract available.

  PMID: 17951284 BACKGROUND

MeSH Terms

Conditions

Arteriosclerosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Study Officials

• Bavana Rangan, BDS, MPH

  UT Southwestern Medical Center/ Dallas VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 15 Years
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty Associate, Cardiology Research

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: June 3, 2016
• Study Start: January 1, 2015
• Primary Completion: March 1, 2017
• Last Updated: September 13, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share