Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial

Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial

Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial

Henry Ford Hospital, Massachusetts General Hospital, North Central Heart-Avera Sacred Heart Hospital, Saint Lukes Hospital Mid America Heart Institute, Missouri Heart Center, University of Washington, Deborah Heart and Lung Center, Minneapolis Heart Institute, Wellspan Heart and Vascular, United Heart and Vascular Clinic and United Hospital

CrossBoss First is a single-blind randomized controlled trial that will randomize 246 patients undergoing clinically-indicated Chronic Total Occlusion Percutaneous Coronary Intervention, to upfront use of the CrossBoss catheter vs. antegrade guidewire escalation strategy The "CrossBoss First" study has two primary objectives. The primary efficacy objective is to compare the procedure time required to cross the CTO or abort the procedure with a CrossBoss first vs. antegrade wire escalation strategy. The investigators hypothesize that upfront use of the CrossBoss catheter will be associated with shorter procedure time required for CTO crossing compared with an antegrade wire escalation strategy. 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.

Incidence of procedural major adverse cardiovascular events (MACE, composite death, emergent coronary artery bypass graft surgery, tamponade requiring pericardiocentesis, and stroke)

Interval between administration of local anesthesia for obtaining vascular access and removal of the last catheter)

Inclusion Criteria: Age 18 years or greater Willing and able to give informed consent Undergoing clinically-indicated CTO PCI with a planned antegrade crossing approach Exclusion Criteria: Plan for primary retrograde approach for CTO crossing Ostial CTOs (within 5 mm of vessel ostium)

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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.