Multicenter LAser VA Registry of Percutaneous Coronary Interventions (LAVA)

NCT ID: NCT02789462

Last Updated: 2017-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Brief Summary

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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

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Conditions

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Arteriosclerosis Coronary Artery Disease Laser-assisted Percutaneous Coronary Interventions

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Patients undergoing laser-assisted PCI

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

Laser-assisted percutaneous coronary interventions

Intervention Type PROCEDURE

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

Interventions

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Laser-assisted percutaneous coronary interventions

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Texas Veterans Healthcare System

FED

Sponsor Role lead

Responsible Party

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Bavana V. Rangan

Faculty Associate, Cardiology Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bavana Rangan, BDS, MPH

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center/ Dallas VA Medical Center

References

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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.

Reference Type BACKGROUND
PMID: 24142769 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15842978 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19626394 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23993124 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23454891 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23332778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17296821 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17470709 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17951284 (View on PubMed)

Other Identifiers

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15075

Identifier Type: -

Identifier Source: org_study_id

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