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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Procedure: CrossBoss Catheter
* Procedure: Antegrade Wire Escalation Strategy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CrossBoss Catheter<br>Crossing the CTO with upfront use of the CrossBoss catheter | Procedure: CrossBoss Catheter<br>* Upfront use of the CrossBoss catheter for CTO lesion crossing<br>|
| Active Comparator: Antegrade Wire Escalation Strategy<br>Crossing the CTO with upfront antegrade wire escalation strategy | Procedure: Antegrade Wire Escalation Strategy<br>* Upfront guidewire escalation strategy for CTO lesion crossing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events | Incidence of procedural major adverse cardiovascular events (MACE, composite death, emergent coronary artery bypass graft surgery, tamponade requiring pericardiocentesis, and stroke) | Until Hospital Discharge (usually 1 day after procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time to Cross the CTO |  | Until end of procedure (usually 2-3 hours after procedure starts) | 
| Technical and procedural success |  | Until end of procedure (usually 2-3 hours after procedure starts) | 
| Total procedure time | Interval between administration of local anesthesia for obtaining vascular access and removal of the last catheter) | Until end of procedure (usually 2-3 hours after procedure starts) | 
| Fluoroscopy time to cross CTO and total fluoroscopy time |  | Until end of procedure (usually 2-3 hours after procedure starts) | 
| Total air kerma radiation exposure |  | Until end of procedure (usually 2-3 hours after procedure starts) | 
| Total contrast volume |  | Until end of procedure (usually 2-3 hours after procedure starts) | 
| Number of wires, microcatheters balloons and stents used. |  | Until end of procedure (usually 2-3 hours after procedure starts) |