Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial
NCT ID: NCT02510547
Last Updated: 2018-01-25
Study Results
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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COMPLETED
PHASE4
246 participants
INTERVENTIONAL
2015-09-30
2017-08-31
Brief Summary
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The primary safety objective is to compare the frequency of procedural major adverse cardiovascular events (MACE) with upfront use of CrossBoss vs. a guidewire escalation strategy. The investigators hypothesize that upfront use of the CrossBoss catheter will be associated with similar incidence of MACE compared with an antegrade wire escalation strategy.
The secondary endpoints are: (1) technical and procedural success4-6; (2) total procedure time (defined as the interval between administration of local anesthesia for obtaining vascular access and removal of the last catheter); (3) fluoroscopy time to cross the CTO and total fluoroscopy time; (4) total air kerma radiation exposure; (5) total contrast volume; and (6) number of wires, microcatheters, balloons, and stents used.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CrossBoss Catheter
Crossing the CTO with upfront use of the CrossBoss catheter
CrossBoss Catheter
Upfront use of the CrossBoss catheter for CTO lesion crossing
Antegrade Wire Escalation Strategy
Crossing the CTO with upfront antegrade wire escalation strategy
Antegrade Wire Escalation Strategy
Upfront guidewire escalation strategy for CTO lesion crossing
Interventions
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CrossBoss Catheter
Upfront use of the CrossBoss catheter for CTO lesion crossing
Antegrade Wire Escalation Strategy
Upfront guidewire escalation strategy for CTO lesion crossing
Eligibility Criteria
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Inclusion Criteria
* Willing and able to give informed consent
* Undergoing clinically-indicated CTO PCI with a planned antegrade crossing approach
Exclusion Criteria
* Ostial CTOs (within 5 mm of vessel ostium)
18 Years
ALL
No
Sponsors
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Henry Ford Hospital
OTHER
Massachusetts General Hospital
OTHER
North Central Heart-Avera Sacred Heart Hospital
UNKNOWN
Saint Lukes Hospital Mid America Heart Institute
UNKNOWN
Missouri Heart Center
UNKNOWN
University of Washington
OTHER
Deborah Heart and Lung Center
OTHER
Minneapolis Heart Institute
OTHER
Wellspan Heart and Vascular
UNKNOWN
United Heart and Vascular Clinic and United Hospital
UNKNOWN
North Texas Veterans Healthcare System
FED
Responsible Party
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Emmanouil Brilakis
Emmanouil Brilakis, MD, PhD
Principal Investigators
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Emmanouil S Brilakis, MD, PhD
Role: STUDY_CHAIR
North Texas Veterans Healthcare System
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
United Heart and Vascular Clinic and United Hospital
Saint Paul, Minnesota, United States
Missouri Heart Center
Columbia, Missouri, United States
St. Luke's Mid America Heart Institute
Kansas City, Missouri, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Wellspan Heart and Vascular
York, Pennsylvania, United States
North Central Heart/Avera Heart Hospital
Sioux Falls, South Dakota, United States
VA North Texas Healthcare System
Dallas, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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References
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Michael TT, Papayannis AC, Banerjee S, Brilakis ES. Subintimal dissection/reentry strategies in coronary chronic total occlusion interventions. Circ Cardiovasc Interv. 2012 Oct;5(5):729-38. doi: 10.1161/CIRCINTERVENTIONS.112.969808.
Wosik J, Shorrock D, Christopoulos G, Kotsia A, Rangan BV, Roesle M, Maragkoydakis S, Abdullah SM, Banerjee S, Brilakis ES. Systematic Review of the BridgePoint System for Crossing Coronary and Peripheral Chronic Total Occlusions. J Invasive Cardiol. 2015 Jun;27(6):269-76.
Other Identifiers
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15-010
Identifier Type: -
Identifier Source: org_study_id
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