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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02510547
First Posted: July 29, 2015
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Henry Ford Hospital
Massachusetts General Hospital
North Central Heart-Avera Sacred Heart Hospital
Saint Lukes Hospital Mid America Heart Institute
Missouri Heart Center
University of Washington
Information provided by (Responsible Party):
Emmanouil Brilakis, North Texas Veterans Healthcare System
  Purpose

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.


Condition Intervention Phase
Arteriosclerosis Coronary Artery Disease Myocardial Ischemia Coronary Disease Procedure: CrossBoss Catheter Procedure: Antegrade Wire Escalation Strategy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Further study details as provided by Emmanouil Brilakis, North Texas Veterans Healthcare System:

Primary Outcome Measures:
  • Major Adverse Cardiovascular Events [ Time Frame: Until Hospital Discharge (usually 1 day after procedure) ]
    Incidence of procedural major adverse cardiovascular events (MACE, composite death, emergent coronary artery bypass graft surgery, tamponade requiring pericardiocentesis, and stroke)


Secondary Outcome Measures:
  • Procedure time to Cross the CTO [ Time Frame: Until end of procedure (usually 2-3 hours after procedure starts) ]
  • Technical and procedural success [ Time Frame: Until end of procedure (usually 2-3 hours after procedure starts) ]
  • Total procedure time [ Time Frame: Until end of procedure (usually 2-3 hours after procedure starts) ]
    Interval between administration of local anesthesia for obtaining vascular access and removal of the last catheter)

  • Fluoroscopy time to cross CTO and total fluoroscopy time [ Time Frame: Until end of procedure (usually 2-3 hours after procedure starts) ]
  • Total air kerma radiation exposure [ Time Frame: Until end of procedure (usually 2-3 hours after procedure starts) ]
  • Total contrast volume [ Time Frame: Until end of procedure (usually 2-3 hours after procedure starts) ]
  • Number of wires, microcatheters balloons and stents used. [ Time Frame: Until end of procedure (usually 2-3 hours after procedure starts) ]

Estimated Enrollment: 246
Study Start Date: September 2015
Study Completion Date: August 2017
Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510547


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
United Heart and Vascular Clinic and United Hospital
Saint Paul, Minnesota, United States, 55102
United States, Missouri
Missouri Heart Center
Columbia, Missouri, United States, 65201
St. Luke's Mid America Heart Institute
Kansas City, Missouri, United States, 64111
United States, New Jersey
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States, 08015
United States, Pennsylvania
Wellspan Heart and Vascular
York, Pennsylvania, United States, 17403
United States, South Dakota
North Central Heart/Avera Heart Hospital
Sioux Falls, South Dakota, United States, 57108
United States, Texas
VA North Texas Healthcare System
Dallas, Texas, United States, 75216
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
North Texas Veterans Healthcare System
Henry Ford Hospital
Massachusetts General Hospital
North Central Heart-Avera Sacred Heart Hospital
Saint Lukes Hospital Mid America Heart Institute
Missouri Heart Center
University of Washington
Investigators
Study Chair: Emmanouil S Brilakis, MD, PhD North Texas Veterans Healthcare System
  More Information

Publications:
Responsible Party: Emmanouil Brilakis, Emmanouil Brilakis, MD, PhD, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT02510547     History of Changes
Other Study ID Numbers: 15-010
First Submitted: July 22, 2015
First Posted: July 29, 2015
Last Update Posted: October 31, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Arteriosclerosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes