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

Completed · Phase 4

Conditions studied: Arteriosclerosis, Coronary Artery Disease, Myocardial Ischemia, Coronary Disease

In brief

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.

Key facts

Study ID

NCT02510547

Run by

North Texas Veterans Healthcare System

People needed

246

Starts

2015-09-01

Expected to finish

2017-08-01

Last updated by the study team

2018-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or greater
• Willing and able to give informed consent
• Undergoing clinically-indicated CTO PCI with a planned antegrade crossing approach

You may not qualify if…

• Plan for primary retrograde approach for CTO crossing
• Ostial CTOs (within 5 mm of vessel ostium)

Where it is running

• 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

Full record on ClinicalTrials.gov

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