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

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ClinicalTrials.gov Identifier: NCT02510547
Recruitment Status : Completed
First Posted : July 29, 2015
Last Update Posted : January 25, 2018
Sponsor:
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
Deborah Heart and Lung Center
Minneapolis Heart Institute
Wellspan Heart and Vascular
United Heart and Vascular Clinic and United Hospital
Information provided by (Responsible Party):
Emmanouil Brilakis, North Texas Veterans Healthcare System

Brief 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.


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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial
Study Start Date : September 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

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




Primary Outcome Measures :
  1. 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 :
  1. Procedure time to Cross the CTO [ Time Frame: Until end of procedure (usually 2-3 hours after procedure starts) ]
  2. Technical and procedural success [ Time Frame: Until end of procedure (usually 2-3 hours after procedure starts) ]
  3. 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)

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

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
Deborah Heart and Lung Center
Minneapolis Heart Institute
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:
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 Posted: July 29, 2015    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

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