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

Summary

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.

Conditions

• Arteriosclerosis
• Coronary Artery Disease
• Myocardial Ischemia
• Coronary Disease

Interventions

PROCEDURE

CrossBoss Catheter

Upfront use of the CrossBoss catheter for CTO lesion crossing

PROCEDURE

Antegrade Wire Escalation Strategy

Upfront guidewire escalation strategy for CTO lesion crossing

Sponsors & Collaborators

• Henry Ford Hospital

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• North Central Heart-Avera Sacred Heart Hospital

  collaborator UNKNOWN

• Saint Lukes Hospital Mid America Heart Institute

  collaborator UNKNOWN

• Missouri Heart Center

  collaborator UNKNOWN

• University of Washington

  collaborator OTHER

• Deborah Heart and Lung Center

  collaborator OTHER

• Minneapolis Heart Institute

  collaborator OTHER

• Wellspan Heart and Vascular

  collaborator UNKNOWN

• United Heart and Vascular Clinic and United Hospital

  collaborator UNKNOWN

• North Texas Veterans Healthcare System

  lead FED

Principal Investigators

• Emmanouil S Brilakis, MD, PhD · North Texas Veterans Healthcare System

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2017-08-31

Completion

2017-08-31

Countries

• United States

Study Locations