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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Coronary Artery Disease; Coronary Disease; Arteriosclerosis
• Intervention / Treatment: Procedure: CrossBoss Catheter; Procedure: Antegrade Wire Escalation Strategy

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute
    • Saint Paul, Minnesota, United States, 55102
      • United Heart and Vascular Clinic and United Hospital
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Missouri Heart Center
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Mid America Heart Institute
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart and Lung Center
  • Pennsylvania
    • York, Pennsylvania, United States, 17403
      • Wellspan Heart and Vascular
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • North Central Heart/Avera Heart Hospital
  • Texas
    • Dallas, Texas, United States, 75216
      • VA North Texas Healthcare System
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: North Texas Veterans Healthcare System
• Collaborators: Massachusetts General Hospital; University of Washington; Minneapolis Heart Institute; Henry Ford Hospital; North Central Heart-Avera Sacred Heart Hospital; Saint Lukes Hospital Mid America Heart Institute; Missouri Heart Center; Deborah Heart and Lung Center; Wellspan Heart and Vascular; United Heart and Vascular Clinic and United Hospital
• Investigators: Study Chair: Emmanouil S Brilakis, MD, PhD, North Texas Veterans Healthcare System

Publications and helpful links

General Publications

• Michael TT, Papayannis AC, Banerjee S, Brilakis ES. Subintimal dissection/reentry strategies in coronary chronic total occlusion interventions. Circ Cardiovasc Interv. 2012 Oct;5(5):729-38. doi: 10.1161/CIRCINTERVENTIONS.112.969808.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: July 22, 2015
• First Submitted That Met QC Criteria: July 26, 2015
• First Posted (Estimate): July 29, 2015

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia; Arteriosclerosis
• Other Study ID Numbers: 15-010