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



Status:Completed
Conditions:Angina, Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/27/2018
Start Date:September 2015
End Date:August 2017

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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.


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)
We found this trial at
11
sites
York, Pennsylvania 17403
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Browns Mills, New Jersey 08015
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Columbia, Missouri 65201
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Columbia, MO
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Dallas, Texas 75216
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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Kansas City, Missouri 64111
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Kansas City, MO
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Minneapolis, Minnesota 55407
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Minneapolis, MN
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225 Smith Avenue North
Saint Paul, Minnesota 55102
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Saint Paul, MN
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Seattle, WA
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4520 West 69th Street
Sioux Falls, South Dakota 57108
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Sioux Falls, SD
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